Compression Instrument Suppliers
Limit companies to: Worldwide USA
ACI Medical, LLC. | Address: 1857 Diamond St., San Marcos, California 92078-5129, USA 
www.acimedical.com | Send Inquiry | Phone: +1-(760)-744-4400
FDA Registration: 2027046 Year Established: 1984 Employee Count: ~20
Products: Diabetic Footwear, External Sequential Compression Devices, Air Plethysmograph, Arterial Circulation Assisting Device, Venous Circulation Assisting Device, Miniature Diaphragm Pumps, ...
ACI Medical, LLC. is a biomedical engineering firm, which focuses on the research, manufacture and sale of therapeutic products. We are FDA registered and accredited with ISO 13485:2003 certification. more...
www.acimedical.com | Send Inquiry | Phone: +1-(760)-744-4400
FDA Registration: 2027046 Year Established: 1984 Employee Count: ~20
Products: Diabetic Footwear, External Sequential Compression Devices, Air Plethysmograph, Arterial Circulation Assisting Device, Venous Circulation Assisting Device, Miniature Diaphragm Pumps, ...
ACI Medical, LLC. is a biomedical engineering firm, which focuses on the research, manufacture and sale of therapeutic products. We are FDA registered and accredited with ISO 13485:2003 certification. 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...
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...
Richardson Products, Incorporated | Address: 9408 Gulfstream Road, Frankfort, Illinois 60423, USA
www.richardsonproducts.com | Send Inquiry | Phone: (888)928-7297
FDA Registration: 3004526603
Products: Foams, Wheelchair Accessories (FDA Code: KNO), Wheelchair Accessories, Battery Charger, Wheelchair Accessories, Positioning Belts, General Medical Equipment, Seating Back Inserts, ...
Richardson Products, Incorporated manufactures a wide range of home medical equipment. Our product offerings include adaptive high tech, dining, headrest hardware & pads, shoe holders, transfer boards more...
www.richardsonproducts.com | Send Inquiry | Phone: (888)928-7297
FDA Registration: 3004526603
Products: Foams, Wheelchair Accessories (FDA Code: KNO), Wheelchair Accessories, Battery Charger, Wheelchair Accessories, Positioning Belts, General Medical Equipment, Seating Back Inserts, ...
Richardson Products, Incorporated manufactures a wide range of home medical equipment. Our product offerings include adaptive high tech, dining, headrest hardware & pads, shoe holders, transfer boards 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...
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...
Alimed, Inc. | Address: 297 High Street, Dedham, Massachusetts 02026, USA
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Exam Lights, Exam Tables, hospital Stools, Medical Examination Lights, Floor Stand Exam Lights, Medical Exam Lights, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Exam Lights, Exam Tables, hospital Stools, Medical Examination Lights, Floor Stand Exam Lights, Medical Exam Lights, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
Depuy Spine, Inc. | Address: 325 Paramount Drive, Raynham, Massachusetts 02767, USA
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
Radi Medical Systems, Inc. | Address: 200 Research Drive, Wilmington, Massachusetts 01887, USA
www.radi.se | Send Inquiry | Phone: +1-(978)-284-6100
Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Guidewires, Passive Closure Devices, FFR-CFR Devices, FFR-CFR Pressure Wires, General EMT, Guidewires Straight, ...
Radi Medical Systems, Inc. manufactures & sells intravascular sensors, hemostasis management, and interventional radiology devices. Our RadiAnalyzer® is a platform for intravascular physiological more...
www.radi.se | Send Inquiry | Phone: +1-(978)-284-6100
Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Guidewires, Passive Closure Devices, FFR-CFR Devices, FFR-CFR Pressure Wires, General EMT, Guidewires Straight, ...
Radi Medical Systems, Inc. manufactures & sells intravascular sensors, hemostasis management, and interventional radiology devices. Our RadiAnalyzer® is a platform for intravascular physiological more...
Gotham Medical LLC | Address: 725 River Road, Suite 32-254, Edgewater, New Jersey 07020, USA
www.gothammedical.com | Send Inquiry | Phone: +1-(201)-608-7169
Products: Bone Taps (FDA Code: HWX), Bone Mill (FDA Code: LYS), Bender (FDA Code: HXW), Bone Cap (FDA Code: JDT), Bone Screw Starter (FDA Code: HWD), Compression Instrument (FDA Code: HWN), ...
Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and t more...
www.gothammedical.com | Send Inquiry | Phone: +1-(201)-608-7169
Products: Bone Taps (FDA Code: HWX), Bone Mill (FDA Code: LYS), Bender (FDA Code: HXW), Bone Cap (FDA Code: JDT), Bone Screw Starter (FDA Code: HWD), Compression Instrument (FDA Code: HWN), ...
Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and t more...
Aircast | Address: 92 River Road, Summit, New Jersey 07901, USA
www.aircast.com | Send Inquiry | Phone: +1-(908)-273-6349, (800)-526-8785
Year Established: 2001 Annual Revenues: USD 100-500 Million Employee Count: ~3000 Quality: ISO, CE Certified
Products: Sequential Compression Devices, Ankle Braces, Elbow Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Aircast develops ankle braces and walking braces. We are an ISO 9001 & CE certified company. We offer products such as ankle braces, walking braces, cold therapy, upper extremity, knee braces & vascul more...
www.aircast.com | Send Inquiry | Phone: +1-(908)-273-6349, (800)-526-8785
Year Established: 2001 Annual Revenues: USD 100-500 Million Employee Count: ~3000 Quality: ISO, CE Certified
Products: Sequential Compression Devices, Ankle Braces, Elbow Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Aircast develops ankle braces and walking braces. We are an ISO 9001 & CE certified company. We offer products such as ankle braces, walking braces, cold therapy, upper extremity, knee braces & vascul more...
Wright Medical Technology, Inc. | Address: 5677 Airline Road, Arlington, Tennessee 38002, USA
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, All Poly Liners, Femoral Components, Total Shoulder Systems, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, All Poly Liners, Femoral Components, Total Shoulder Systems, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
EBI Patient Care, Inc. | Address: 1 Electro-biology Blvd., Guaynabo 00657, USA
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Zimmer Dental, Inc. | Address: 1900 Aston Ave., Carlsbad, California 92008, USA
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, Bone Graft Substitute Blocks, Bone Graft Substitute Osteotomy Wedges, Bone Graft Harvester, Allograft Bone Graft, ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, Bone Graft Substitute Blocks, Bone Graft Substitute Osteotomy Wedges, Bone Graft Harvester, Allograft Bone Graft, ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
Interventional Spine, Inc. | Address: 13700 Alton Pkwy., Suite 160, Irvine, California 92618, USA
www.i-spineinc.com | Send Inquiry | Phone: +1-(949)-472-0006, 800-497-0484
Year Established: 2000
Products: Tissue Retractors, Facet Screw Spinal Device System (FDA Code: MRW), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Nut Bolt Washer (FDA Code: HTN), Bilateral Facet Augmentation Systems, Pedicular Compression Systems, ...
Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of more...
www.i-spineinc.com | Send Inquiry | Phone: +1-(949)-472-0006, 800-497-0484
Year Established: 2000
Products: Tissue Retractors, Facet Screw Spinal Device System (FDA Code: MRW), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Nut Bolt Washer (FDA Code: HTN), Bilateral Facet Augmentation Systems, Pedicular Compression Systems, ...
Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of more...
Seaspine | Address: 2302 La Mirada Drive, Vista, California 92081-7862, USA
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Anterior Cervical Plate, Bone Graft Harvester, General use Surgical Curettes (FDA Code: FZS), Manual Surgical Chisel (FDA Code: FZO), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Anterior Cervical Plate, Bone Graft Harvester, General use Surgical Curettes (FDA Code: FZS), Manual Surgical Chisel (FDA Code: FZO), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
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FDA Code / Regulation: HWN / 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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