Orthopedic Manual Surgical Instrument Suppliers
Limit companies to: Worldwide USA
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...
OMNI life science, Inc. | Address: 175 Paramount dr., Raynham, Massachusetts 02767, USA
www.omnils.com | Send Inquiry | Phone: +1-(508)-824-2444
Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 13485 ,CE Certification, MDSS Certification Certified
Products: Humeral Splints, Lower Extremity Splints, Orthoses, Humeral Splints, Adjustable Ankle Support, Air Ankle Support, Ankle Support, ...
Omni Life Science designs, produces and distributes orthotic devices. We specialize in knee bracing and measurement systems. We offer products like hip & knee reconstruction. Our Apex Modular™ f more...
www.omnils.com | Send Inquiry | Phone: +1-(508)-824-2444
Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 13485 ,CE Certification, MDSS Certification Certified
Products: Humeral Splints, Lower Extremity Splints, Orthoses, Humeral Splints, Adjustable Ankle Support, Air Ankle Support, Ankle Support, ...
Omni Life Science designs, produces and distributes orthotic devices. We specialize in knee bracing and measurement systems. We offer products like hip & knee reconstruction. Our Apex Modular™ f more...
Blackstone Medical, Inc. | Address: 90 Brookdale Drive, Springfield, Massachusetts 01104, USA
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
Thompson Surgical Instruments, Inc. | Address: 10170 E Cherry Bend Rd, Traverse City, Massachusetts 49684, USA
www.thompsonsurgical.com | Send Inquiry | Phone: +1-(231)-922-0177,800-227-7543
FDA Registration: 1450428 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, Flexible Scope Holder, Laparoscopic Retractor, ...
Thompson Surgical Instruments, Inc. produces a mechanical retractor which offers one frame for all exposure needs, multi-planed retraction and unlimited customization. Our anterior cervical access kit more...
www.thompsonsurgical.com | Send Inquiry | Phone: +1-(231)-922-0177,800-227-7543
FDA Registration: 1450428 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, Flexible Scope Holder, Laparoscopic Retractor, ...
Thompson Surgical Instruments, Inc. produces a mechanical retractor which offers one frame for all exposure needs, multi-planed retraction and unlimited customization. Our anterior cervical access kit more...
Aspen Surgical Products | Address: 6945 Southbelt Dr. SE, Caledonia, Michigan 49316, USA
www.aspensurgical.com | Send Inquiry | Phone: +1-(616)-698-7100, 888-364-7004
FDA Registration: 1836161 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Vascular Clamps (FDA Code: DXC), Metal Skull Clamps, ...
Aspen Surgical Products deals with medical products. We are an ISO: 13485 certified and FDA-registered facility We carry an extensive line of products including operating room disposables, wound care more...
www.aspensurgical.com | Send Inquiry | Phone: +1-(616)-698-7100, 888-364-7004
FDA Registration: 1836161 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Clamps, General Medical Supplies, General Surgical Instruments, Suture Needles, Vascular Clamps (FDA Code: DXC), Metal Skull Clamps, ...
Aspen Surgical Products deals with medical products. We are an ISO: 13485 certified and FDA-registered facility We carry an extensive line of products including operating room disposables, wound care more...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
Medtronic, Inc. | Address: 710 Medtronic Parkway, Minneapolis, Minnesota 55432-5604, USA
www.medtronic.com | Send Inquiry | Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: EMG Electrodes, Bioprosthesis, Pulmonary Valved Conduit, Transcatheter Pulmonary Valve, Transcatheter Delivery System, Single Fiber EMG Software, Non-invasive Magnetic Stimulation System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu more...
www.medtronic.com | Send Inquiry | Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: EMG Electrodes, Bioprosthesis, Pulmonary Valved Conduit, Transcatheter Pulmonary Valve, Transcatheter Delivery System, Single Fiber EMG Software, Non-invasive Magnetic Stimulation System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu more...
Osteotech, Inc. | Address: 51 James Way, Eatontown, New Jersey 07724, USA
www.osteotech.com | Send Inquiry | Phone: +1-(732)-542-2800
FDA Registration: 2249915 Year Established: 1986 Annual Revenues: USD 50-100 Million Employee Count: ~360
Products: Demineralized Bone Matrix, Allografts, Human Demineralized Bone Matrix, Osteoinductive Demineralized Bone Matrix, Soft Tissue Allografts, Bone Allografts, ...
Osteotech, Inc. specializes in the processing of human bone & connective tissue for transplantation and create, assemble & distribute biologic, biomaterial & device systems for musculoskeletal surgery more...
www.osteotech.com | Send Inquiry | Phone: +1-(732)-542-2800
FDA Registration: 2249915 Year Established: 1986 Annual Revenues: USD 50-100 Million Employee Count: ~360
Products: Demineralized Bone Matrix, Allografts, Human Demineralized Bone Matrix, Osteoinductive Demineralized Bone Matrix, Soft Tissue Allografts, Bone Allografts, ...
Osteotech, Inc. specializes in the processing of human bone & connective tissue for transplantation and create, assemble & distribute biologic, biomaterial & device systems for musculoskeletal surgery 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...
Endotec, Inc. | Address: 20 Valley Street, South Orange, New Jersey 07079, USA
www.endotec.com | Send Inquiry | Phone: +1-(973)-672-9300
FDA Registration: 3006001176
Products: Bone Fixation Screw (FDA Code: HWC), Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD), Humeral Shoulder Prosthesis (FDA Code: MJT), Hip Joint (Hemi- Hip) Acetabular Metal Cemented Prosthesis (FDA Code: KWB), Femoral Metal Ball Hemi Hip Prosthesis (FDA Code: LZY), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), ...
Endotec, Inc. is a manufacturer, distributor & designer of orthopedic and maxillofacial implants. We offer products such as hip system, shoulder system, knee system & TMJ system. We offer the B-P inte more...
www.endotec.com | Send Inquiry | Phone: +1-(973)-672-9300
FDA Registration: 3006001176
Products: Bone Fixation Screw (FDA Code: HWC), Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD), Humeral Shoulder Prosthesis (FDA Code: MJT), Hip Joint (Hemi- Hip) Acetabular Metal Cemented Prosthesis (FDA Code: KWB), Femoral Metal Ball Hemi Hip Prosthesis (FDA Code: LZY), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), ...
Endotec, Inc. is a manufacturer, distributor & designer of orthopedic and maxillofacial implants. We offer products such as hip system, shoulder system, knee system & TMJ system. We offer the B-P inte more...
Conmed Corporation | Address: 525 French Road, Utica, New York 13502, USA
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: 80° Vertical Microscissors, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Active Electrosurgical Electrode (FDA Code: FAS), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: 80° Vertical Microscissors, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Active Electrosurgical Electrode (FDA Code: FAS), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Nemcomed | Address: 801 Industrial Dr., Hicksville, Ohio 43526, USA
www.nemcomed.com | Send Inquiry | Phone: +1-(800)-255-4576
Year Established: 1976 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Bone Awls and Probes, AWLS, Bone Screws, Bone Mill (FDA Code: LYS), Army Pattern Chisel, Axial Lumbar Curette, ...
Nemcomed is an ISO 13485:2003 certified company. We develop and manufacture precision medical devices. Our collateral soft tissue protector protects and preserves collateral soft tissue during bone re more...
www.nemcomed.com | Send Inquiry | Phone: +1-(800)-255-4576
Year Established: 1976 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Bone Awls and Probes, AWLS, Bone Screws, Bone Mill (FDA Code: LYS), Army Pattern Chisel, Axial Lumbar Curette, ...
Nemcomed is an ISO 13485:2003 certified company. We develop and manufacture precision medical devices. Our collateral soft tissue protector protects and preserves collateral soft tissue during bone re more...
Conmed Integrated Systems | Address: 1815 NW 169th Place, Suite 4020, Beaverton, Oregon 97006, USA
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Integrated OR Systems, Arthroscopy Instruments, Electrosurgery, Endoscopy Devices, Patient Care Suction Apparatus (FDA Code: DWM), Integrated Diagnostic Systems, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Integrated OR Systems, Arthroscopy Instruments, Electrosurgery, Endoscopy Devices, Patient Care Suction Apparatus (FDA Code: DWM), Integrated Diagnostic Systems, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Kensey Nash Corporation | Address: 735 Pennsylvania Drive, Exton, Pennsylvania 19341, USA
www.kenseynash.com | Send Inquiry | Phone: +1-(484)-713-2100
FDA Registration: 2530154 Year Established: 1984 Annual Revenues: USD 50-100 Million Employee Count: ~360 Quality: ISO 9001, CE Certified
Products: Product Design & Development, Distal Embolic Protection Devices, Embolic Protection System, Guide Catheter, Embolic Protection, Vascular Closure Device, Extraction Catheter, ...
Kensey Nash Corporation is a medical device company that deals with the development of a wide variety of products for the cardiovascular, endovascular, sports medicine, spine and trauma marketplaces. more...
www.kenseynash.com | Send Inquiry | Phone: +1-(484)-713-2100
FDA Registration: 2530154 Year Established: 1984 Annual Revenues: USD 50-100 Million Employee Count: ~360 Quality: ISO 9001, CE Certified
Products: Product Design & Development, Distal Embolic Protection Devices, Embolic Protection System, Guide Catheter, Embolic Protection, Vascular Closure Device, Extraction Catheter, ...
Kensey Nash Corporation is a medical device company that deals with the development of a wide variety of products for the cardiovascular, endovascular, sports medicine, spine and trauma marketplaces. more...
Orthovita | Address: 77 Great Valley Parkway, Malvern, Pennsylvania 19355, USA
www.orthovita.com | Send Inquiry | Phone: +1-(610)-640-1775
FDA Registration: 2530131 Year Established: 1992
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Hydroxyapatite, Artificial Hydroxyapatite Orbital Implant, Bio-Eyes Hydroxyapatite Orbital Implant, Porous hydroxyapatite orbital implants, ...
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fra more...
www.orthovita.com | Send Inquiry | Phone: +1-(610)-640-1775
FDA Registration: 2530131 Year Established: 1992
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Hydroxyapatite, Artificial Hydroxyapatite Orbital Implant, Bio-Eyes Hydroxyapatite Orbital Implant, Porous hydroxyapatite orbital implants, ...
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fra more...
Small Bone Innovations, Inc | Address: 1380 S. Pennsylvania Avenue, Morrisville, Pennsylvania 19067, USA
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: CMC and IP Joint Implants, Biaxial Total Wrist Arthroplasty, Carpal Fusion Plate, Dorsal Distal Radius Plate, Elbow Implant, Proximal Radial Head Prosthesis, Elbow Implant, Recon Prosthesis, ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
www.totalsmallbone.com | Phone: +1-(215)-428-1791
Products: CMC and IP Joint Implants, Biaxial Total Wrist Arthroplasty, Carpal Fusion Plate, Dorsal Distal Radius Plate, Elbow Implant, Proximal Radial Head Prosthesis, Elbow Implant, Recon Prosthesis, ...
Small Bone Innovations, Inc. delivers arthroplasty, fixation, trauma and biologic solutions. Our Head™ proximal radial head is designed to anatomically articulate with the convexity of the capit more...
Millennium Surgical Corp. | Address: 822 Montgomery Ave, #205, Narberth, Pennsylvania 19072, USA
www.surgicalinstruments.com | Send Inquiry | Phone: +1-(610)-771.0850
FDA Registration: 3004215117
Products: Autoclaves, Automatic Autoclaves, Adjustable Mastoid Retractor, Arteriotomy Clamp, Aspirators And Accessories, Anterior Cervical Fusion Longitudinal Retractor, ...
Millennium Surgical Corp. deals with surgical instruments of all specialties. Our product range comprises of instrument trays, eye surgical instruments, eye needles & cannulas, diamond knives, eye dra more...
www.surgicalinstruments.com | Send Inquiry | Phone: +1-(610)-771.0850
FDA Registration: 3004215117
Products: Autoclaves, Automatic Autoclaves, Adjustable Mastoid Retractor, Arteriotomy Clamp, Aspirators And Accessories, Anterior Cervical Fusion Longitudinal Retractor, ...
Millennium Surgical Corp. deals with surgical instruments of all specialties. Our product range comprises of instrument trays, eye surgical instruments, eye needles & cannulas, diamond knives, eye dra more...
Superior Surgical | Address: 176 Clover Lane, Perkiomenville, Pennsylvania 18074, USA
www.superior-surgical.com | Send Inquiry | Phone: +1-(877)-669-7646
FDA Registration: 3008017452
Products: Ophthalmic Solutions, Disposable Ophthalmic Cannulae, Ophthalmic Needles, Ophthalmic Surgery Knives, Ophthalmic Surgical Drapes, Ophthalmic Surgical Sponges, ...
Superior Surgical offers surgical products to hospitals and physicians. We also specialize in ophthalmic disposables and surgical instruments/power equipment repair. We offer eye surgical instruments, more...
www.superior-surgical.com | Send Inquiry | Phone: +1-(877)-669-7646
FDA Registration: 3008017452
Products: Ophthalmic Solutions, Disposable Ophthalmic Cannulae, Ophthalmic Needles, Ophthalmic Surgery Knives, Ophthalmic Surgical Drapes, Ophthalmic Surgical Sponges, ...
Superior Surgical offers surgical products to hospitals and physicians. We also specialize in ophthalmic disposables and surgical instruments/power equipment repair. We offer eye surgical instruments, 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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