Awl Suppliers
Limit companies to: Worldwide USA
Orthofix Inc. | Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA 
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery 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...
Joimax, Inc. | Address: 275 E. Hacienda Avenue, Campbell, California 95008, USA
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Electrosurgical Systems, Irrigation Pumps, Disposable Surgical Instrument Kit (FDA Code: KDD), Endoscopic Surgical Light (FDA Code: FSW), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis more...
www.joimaxusa.com | Send Inquiry | Phone: +1-(408)-370-3005
FDA Registration: 3005042595
Products: Light Sources, Electrosurgical Systems, Irrigation Pumps, Disposable Surgical Instrument Kit (FDA Code: KDD), Endoscopic Surgical Light (FDA Code: FSW), Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS), ...
Joimax, Inc. deals with endoscopic spinal surgery. We offer Tessys®, video twister™, C-camsource®, jIFP 2000™, Surgimax™ and JFM 1910™. Our Tessys® spinal stenosis 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...
Spinevision, Inc. | Address: 301 Howard St., Suite 970, San Francisco, California 94105, USA
www.spinevision.net | Phone: +1-(415)-5128001
FDA Registration: 1067145
Products: Cervical Spine Retractor System, Hand Held Instruments, Spinal Implants, SpineAssist System, Prosthesis Driver (FDA Code: HWR), Anterior Cervical Plate Systems, Thoraco-Lumbar Spinal Systems, ...
Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system h more...
www.spinevision.net | Phone: +1-(415)-5128001
FDA Registration: 1067145
Products: Cervical Spine Retractor System, Hand Held Instruments, Spinal Implants, SpineAssist System, Prosthesis Driver (FDA Code: HWR), Anterior Cervical Plate Systems, Thoraco-Lumbar Spinal Systems, ...
Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system h 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...
Lenox Maclaren | Address: 657 S. Taylor Avenue, Suite A, Louisville, Colorado 80027, USA
www.lenoxmaclaren.com | Send Inquiry | Phone: +1-(866)-890-9660
FDA Registration: 1722824 Year Established: 1983 Annual Revenues: USD 1-5 Million
Products: Curettes, Instruments surgical, Rodcutters, Bone Mill (FDA Code: LYS), Instrument Sterilization Tray, Retractors, ...
Lenox Maclaren specializes in custom instrument design and fabricatrion. Our product list comprises of bone mills, table top rod cutter, retractors, and instrument sterilization trays. Our bone mill i more...
www.lenoxmaclaren.com | Send Inquiry | Phone: +1-(866)-890-9660
FDA Registration: 1722824 Year Established: 1983 Annual Revenues: USD 1-5 Million
Products: Curettes, Instruments surgical, Rodcutters, Bone Mill (FDA Code: LYS), Instrument Sterilization Tray, Retractors, ...
Lenox Maclaren specializes in custom instrument design and fabricatrion. Our product list comprises of bone mills, table top rod cutter, retractors, and instrument sterilization trays. Our bone mill i more...
Spine Wave, Inc. | Address: Three Enterprise Drive, Suite 210, Shelton, Connecticut 06484, USA
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Pedicle Screw System, Vertebral Body Replacement System, Medical Devices, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Pedicle Screw System, Vertebral Body Replacement System, Medical Devices, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Inion, Inc. | Address: 2800 Glades Circle, Suite 138, Weston, Florida 33327, USA
www.inion.com | Send Inquiry | Phone: +1-(954)-659-9224
FDA Registration: 3003547707 Year Established: 2000
Products: Bone Plate Wrench, Foot & Ankle External Fixation System, Bone Screws, Bone Regeneration, Distal Radius Plates, Arthroscopic Handheld Instrument, ...
Inion, Inc. is a medical device company that focuses on the development and commercialization of biodegradable & bioactive implants. Our products include biodegradable plates, screws, pins and membran more...
www.inion.com | Send Inquiry | Phone: +1-(954)-659-9224
FDA Registration: 3003547707 Year Established: 2000
Products: Bone Plate Wrench, Foot & Ankle External Fixation System, Bone Screws, Bone Regeneration, Distal Radius Plates, Arthroscopic Handheld Instrument, ...
Inion, Inc. is a medical device company that focuses on the development and commercialization of biodegradable & bioactive implants. Our products include biodegradable plates, screws, pins and membran more...
Hu-Friedy | Address: 3232 N.Rockwell, Chicago, Illinois 60618-5982, USA
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Adson-Graefe Tissue Forceps, Adson 1 x 2 Teeth Tissue Forceps, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Adjustable Bone Holding Forceps, Adson Needle Holder, ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
www.hu-friedy.com | Send Inquiry | Phone: +001-(800)-483-7433
FDA Registration: 1416605 Year Established: 1908 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Adson-Graefe Tissue Forceps, Adson 1 x 2 Teeth Tissue Forceps, Absorbable Hemostats Surgicel, 80° Vertical Microscissors, Adjustable Bone Holding Forceps, Adson Needle Holder, ...
Hu-Friedy offers a wide range of periodontal, restorative, diagnostic, surgery and orthodontic instruments. We specialize in manufacturing quality handheld dental instruments. We develop the next gene more...
Zoll Dental | Address: 7450 North Natchez Ave., Niles, Illinois 60714, USA
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Scissors, Dental Forceps, orthodontic pliers, Dental Devices, Dental Bone File, Tissue Pliers, ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Scissors, Dental Forceps, orthodontic pliers, Dental Devices, Dental Bone File, Tissue Pliers, ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Retractor System, General Surgical Instruments, Titanium Microsurgical Instruments, Orthopedic Instruments, Maxillofacial Prosthesis, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
Symmetry Medical USA, Inc. | Address: 486 West 350 North, Warsaw, Indiana 46582, USA
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Blade Holders, Arthroscopy, Hook Knife, Arthroscopy, Meniscutome, Acetabular Cup System, Awl (FDA Code: HWJ), Curettes (FDA Code: HTF), ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Blade Holders, Arthroscopy, Hook Knife, Arthroscopy, Meniscutome, Acetabular Cup System, Awl (FDA Code: HWJ), Curettes (FDA Code: HTF), ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Holmed Corporation | Address: 40 Norfolk Avenue, South Easton, Massachusetts 2375, USA
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Bipolar Forceps, Bone Awls and Probes, Large Solid Mallet, Bone Taps (FDA Code: HWX), Orthopedic Implant, Wire Tightner Cum Twister, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Bipolar Forceps, Bone Awls and Probes, Large Solid Mallet, Bone Taps (FDA Code: HWX), Orthopedic Implant, Wire Tightner Cum Twister, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
Pioneer Surgical Technology | Address: 375 River Park Circle, Marquette, Michigan 49855, USA
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Modular Sternal Cable System, Anterior Cervical Plating System, Surgical Instrument Tray (FDA Code: FSM), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bone Fixation Screw (FDA Code: HWC), Spinal Fixation Device Implant (FDA Code: JDN), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Modular Sternal Cable System, Anterior Cervical Plating System, Surgical Instrument Tray (FDA Code: FSM), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bone Fixation Screw (FDA Code: HWC), Spinal Fixation Device Implant (FDA Code: JDN), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
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FDA Code / Regulation: HWJ / 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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