Orthopedic Manual Surgical Instrument Suppliers
Limit companies to: Worldwide USA
W. l. Gore & Associates, Inc. | Address: P.O. Box 2400, Flagstaff, Arizona 86003-2400, USA 
www.goremedical.com | Send Inquiry | Phone: +1-(928)-779-2771, 800 -437-8181
FDA Registration: 3013164176
Products: Aortic Stent Systems, Bifurcated Stretch Vascular Grafts, Absorbable Surgical Sutures, Absorbable Dural Substitute, Bioabsorbable Hernia Plug, Burn Sheet (FDA Code: FPY), ...
W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a more...
www.goremedical.com | Send Inquiry | Phone: +1-(928)-779-2771, 800 -437-8181
FDA Registration: 3013164176
Products: Aortic Stent Systems, Bifurcated Stretch Vascular Grafts, Absorbable Surgical Sutures, Absorbable Dural Substitute, Bioabsorbable Hernia Plug, Burn Sheet (FDA Code: FPY), ...
W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a more...
Hayes Medical, Inc. | Address: 1115 Windfield Way, Ste. 100, El Dorado Hills, California 95762-9623, USA
www.hayesmed.com | Send Inquiry | Phone: +1-(916)-355-7100
FDA Registration: 2952369 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Tibial Inserts, Patellar Implants, Hip Positioner Systems, Total Knee Systems, Compression Garments, Knee/Ankle Braces & Supports, ...
Hayes Medical, Inc. concentrates on the orthopaedic implant and instrument industry. Our Consensus® hip system offers the surgeon a variety of implant options, thus providing excellent performance more...
www.hayesmed.com | Send Inquiry | Phone: +1-(916)-355-7100
FDA Registration: 2952369 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Tibial Inserts, Patellar Implants, Hip Positioner Systems, Total Knee Systems, Compression Garments, Knee/Ankle Braces & Supports, ...
Hayes Medical, Inc. concentrates on the orthopaedic implant and instrument industry. Our Consensus® hip system offers the surgeon a variety of implant options, thus providing excellent performance more...
Depuy Orthopaedics, Inc. | Address: 4240 Holden Street, Emeryville, California 94608, USA
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Acetabular Liners, AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), AC-Powered Surgical Instrument Motor (FDA Code: GEY), 3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Acetabular Mesh Hip Prosthesis (FDA Code: JDJ), ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Acetabular Liners, AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), AC-Powered Surgical Instrument Motor (FDA Code: GEY), 3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Acetabular Mesh Hip Prosthesis (FDA Code: JDJ), ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
Nuvasive Inc. | Address: 4545, Towne Centre Court, San Diego, California 92121, USA
www.nuvasive.com | Send Inquiry | Phone: +1-(800)-455-1476
FDA Registration: 2031966 Year Established: 1997
Products: Facet Screws, Translaminar Facet Screws, Transarticular Facet Screws, Bilateral Facet Screws, Evaluated Facet Screws, Posterior Cervical Plating Systems, ...
Nuvasive Inc. focuses on the design, development and marketing of products for the surgical treatment of spinal disorders. We provide safe & reproductive procedural solutions with platform technology more...
www.nuvasive.com | Send Inquiry | Phone: +1-(800)-455-1476
FDA Registration: 2031966 Year Established: 1997
Products: Facet Screws, Translaminar Facet Screws, Transarticular Facet Screws, Bilateral Facet Screws, Evaluated Facet Screws, Posterior Cervical Plating Systems, ...
Nuvasive Inc. focuses on the design, development and marketing of products for the surgical treatment of spinal disorders. We provide safe & reproductive procedural solutions with platform technology more...
DJ Orthopedics Inc. | Address: 2985 Scott Street, Vista, California 92081, USA
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, External Bone Growth Stimulators, Back Braces & Supports, Centrifuges, Aspirators, Casting Materials, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, External Bone Growth Stimulators, Back Braces & Supports, Centrifuges, Aspirators, Casting Materials, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
Sontec Instruments, Inc. | Address: 7248 South Tucson Way, Colorado 80112, USA
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
Innovative Medical Products, Inc | Address: 87 Spring Lane, Plainville, Connecticut 06062, USA
www.innovativemedical.com | Send Inquiry | Phone: +1-(860)-793-0391
FDA Registration: 1223419 Year Established: 1983 Quality: CE Certified
Products: Splints, Hip Positioner Systems, Leg Positioners, Casting Stands, Tibial Distractors, Casting Materials, ...
Innovative Medical Products, Inc specializes in the areas of orthopaedic surgery, radiology, anesthesia and home healthcare. We offer products such as hip positioners, knee positioners, shoulder posit more...
www.innovativemedical.com | Send Inquiry | Phone: +1-(860)-793-0391
FDA Registration: 1223419 Year Established: 1983 Quality: CE Certified
Products: Splints, Hip Positioner Systems, Leg Positioners, Casting Stands, Tibial Distractors, Casting Materials, ...
Innovative Medical Products, Inc specializes in the areas of orthopaedic surgery, radiology, anesthesia and home healthcare. We offer products such as hip positioners, knee positioners, shoulder posit more...
Exactech, Inc. | Address: 2320 North West 66th Court, Gainesville, Florida 32653, USA
www.exac.com | Send Inquiry | Phone: +1-(352)-377-1140, 800-392-2832
FDA Registration: 1038671 Year Established: 1985 Annual Revenues: USD 50-100 Million Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Patellar Implants, Primary Femoral Implants, Bone Cement (FDA Code: LOD), Unipolar Endoprosthesis, Bipolar Endoprosthesis, Fracture Prosthesis, ...
Exactech, Inc. is an orthopedic company that develops, manufactures, markets, distributes and sells orthopedic implant devices, related surgical instrumentation & biologic services to hospitals & phys more...
www.exac.com | Send Inquiry | Phone: +1-(352)-377-1140, 800-392-2832
FDA Registration: 1038671 Year Established: 1985 Annual Revenues: USD 50-100 Million Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Patellar Implants, Primary Femoral Implants, Bone Cement (FDA Code: LOD), Unipolar Endoprosthesis, Bipolar Endoprosthesis, Fracture Prosthesis, ...
Exactech, Inc. is an orthopedic company that develops, manufactures, markets, distributes and sells orthopedic implant devices, related surgical instrumentation & biologic services to hospitals & phys more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Scient'x USA Inc. | Address: 1015 Maitland Center Commons,Suite 106A, Maitland, Florida 32751, USA
www.scientxusa.com | Send Inquiry | Phone: +1-(,407)-571-2550
Year Established: 2002 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Synthetic Spacers, Bioabsorbable synthetic spacers, Removable synthetic spacers, Stellar Cervical Plate, Pantheon T Cervical Plate, PEEK Spacer System, ...
Scient'x USA Inc. offers a wide range of anterior and posterior spinal fixation systems, which include proprietary semi-rigid lumbar system technology, its peek devices, its cervical plate, as well as more...
www.scientxusa.com | Send Inquiry | Phone: +1-(,407)-571-2550
Year Established: 2002 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Synthetic Spacers, Bioabsorbable synthetic spacers, Removable synthetic spacers, Stellar Cervical Plate, Pantheon T Cervical Plate, PEEK Spacer System, ...
Scient'x USA Inc. offers a wide range of anterior and posterior spinal fixation systems, which include proprietary semi-rigid lumbar system technology, its peek devices, its cervical plate, as well as more...
Arthrex, Inc. | Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo more...
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo more...
Innomed, Inc. | Address: 103 Estus Drive, Savannah, Georgia 31404, USA
www.innomed.net | Send Inquiry | Phone: +1-(912)-236-0000
FDA Registration: 1833053
Products: Curettes, Elevators, Mallets, Retractors, Rongeurs, Self-Retaining Retractors (FDA Code: FFO), ...
Innomed, Inc. produces surgical instruments for orthopaedic surgery. We offer instruments like hip instrument, knee instrument, shoulder & elbow instrument, and spine instrument. We create femoral hea more...
www.innomed.net | Send Inquiry | Phone: +1-(912)-236-0000
FDA Registration: 1833053
Products: Curettes, Elevators, Mallets, Retractors, Rongeurs, Self-Retaining Retractors (FDA Code: FFO), ...
Innomed, Inc. produces surgical instruments for orthopaedic surgery. We offer instruments like hip instrument, knee instrument, shoulder & elbow instrument, and spine instrument. We create femoral hea more...
Brasseler USA | Address: 1 Brasseler Boulevard, Savannah, Georgia 31419, USA
www.brasselerusamedical.com | Send Inquiry | Phone: +1-(800)-535-6638
FDA Registration: 2025102 Year Established: 1987 Employee Count: ~150 Quality: ISO, CE Certified
Products: Pneumatic Neurosurgical Drill Systems, Large Bone Battery Power System, Small Bone Pneumatic Power Systems, High Speed Drills, Small Bone Electric Power Systems, Orthopedics, High Speed Drills System, ...
Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sel more...
www.brasselerusamedical.com | Send Inquiry | Phone: +1-(800)-535-6638
FDA Registration: 2025102 Year Established: 1987 Employee Count: ~150 Quality: ISO, CE Certified
Products: Pneumatic Neurosurgical Drill Systems, Large Bone Battery Power System, Small Bone Pneumatic Power Systems, High Speed Drills, Small Bone Electric Power Systems, Orthopedics, High Speed Drills System, ...
Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sel more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Paragon Medical, Inc. | Address: 8 Matchett Industrial Park Drive, Pierceton, Indiana 46562, USA
www.paragonmedical.com | Send Inquiry | Phone: +1-(574)-594-2140, 800-225-6975
FDA Registration: 1834331 Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~600 Quality: ISO 9001 Certified
Products: Procedure Trays, General Medical Supplies, Medical Procedure Trays, Operating Procedure Trays, Procedure TrayS For Surgery, Sterile Procedure Trays, ...
Paragon Medical, Inc. provides solutions for cases & trays, surgical instrumentation, and implantable components. ChromaSim is our tool for exploring our color options for cases & trays and surgical i more...
www.paragonmedical.com | Send Inquiry | Phone: +1-(574)-594-2140, 800-225-6975
FDA Registration: 1834331 Year Established: 1991 Annual Revenues: USD 1-5 Million Employee Count: ~600 Quality: ISO 9001 Certified
Products: Procedure Trays, General Medical Supplies, Medical Procedure Trays, Operating Procedure Trays, Procedure TrayS For Surgery, Sterile Procedure Trays, ...
Paragon Medical, Inc. provides solutions for cases & trays, surgical instrumentation, and implantable components. ChromaSim is our tool for exploring our color options for cases & trays and surgical i more...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
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FDA Code / Regulation: LXH / 888.4540
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 888.9.
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