Broach Suppliers
Limit companies to: Worldwide USA
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...
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...
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...
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...
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...
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...
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...
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...
SIM Surgical | Address: 1650 Headland Drive, St. Louis, Missouri 63026, USA
www.simsurgical.com | Send Inquiry | Phone: +1-(800)-521-2985
FDA Registration: 1935627 Year Established: 2001 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 13485 Certified
Products: Common Surgical Instrument, Packaging, Repair Service for Medical Instruments, Thread Whirled Monoaxial Screws, Thread Whirled Polyaxial Screws, Titanium Interbody Devices, ...
SIM Surgical is a contract manufacturer of surgical instruments. Our product portfolio comprises of implants and instruments. more...
www.simsurgical.com | Send Inquiry | Phone: +1-(800)-521-2985
FDA Registration: 1935627 Year Established: 2001 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 13485 Certified
Products: Common Surgical Instrument, Packaging, Repair Service for Medical Instruments, Thread Whirled Monoaxial Screws, Thread Whirled Polyaxial Screws, Titanium Interbody Devices, ...
SIM Surgical is a contract manufacturer of surgical instruments. Our product portfolio comprises of implants and instruments. more...
Greatbatch Medical, Inc., | Address: 10000 Wehrle Drive, Clarence, New York 14031, USA
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Amputation Saws, Cortical Screws, Dental Implants, Compression Screw, Cancellous Bone Screw, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Amputation Saws, Cortical Screws, Dental Implants, Compression Screw, Cancellous Bone Screw, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
Synthes (USA) | Address: 35 Airport Road, Horseheads, New York 14845, USA
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
Aesculap Implant Systems, Inc. | Address: #3773, Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
Chattanooga Group | Address: 4717 Adams Road, Hixson, Tennessee 37343, USA
www.chattgroup.com | Phone: +1-(423)-870.2281, 800.592.7329
Year Established: 1947 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Carts, Chairs & stools, Compression Garments, Cryosurgery, EKG Supplies, Exam Tables, ...
Chattanooga Group produces rehabilitation equipment for treating skeletal, muscular, neurological and soft tissue disorders. Our laser therapy uses light to penetrate tissue for increased blood flow a more...
www.chattgroup.com | Phone: +1-(423)-870.2281, 800.592.7329
Year Established: 1947 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Carts, Chairs & stools, Compression Garments, Cryosurgery, EKG Supplies, Exam Tables, ...
Chattanooga Group produces rehabilitation equipment for treating skeletal, muscular, neurological and soft tissue disorders. Our laser therapy uses light to penetrate tissue for increased blood flow a more...
Spine Smith L.P. | Address: 93 Red River, Austin, Texas 78701, USA
Send Inquiry | Phone: +1-(512)-206-0770
FDA Registration: 3006404071
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), Drill Brace (FDA Code: HXY), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biolog more...
Send Inquiry | Phone: +1-(512)-206-0770
FDA Registration: 3006404071
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), Drill Brace (FDA Code: HXY), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biolog more...
Encore Medical, L.P. | Address: 9800 Metric Blvd., Austin, Texas 78758, USA
www.djosurgical.com | Phone: +1-(512)-832-9500, 800-456-8696
FDA Registration: 1644408
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Orthopedic Burr (FDA Code: HTT), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Prosthesis Driver (FDA Code: HWR), ...
Encore Medical, L.P. is a designer, manufacturer and distributor of orthopedic surgery products. Our Reverse® shoulder prosthesis is indicated for use in patients with a functional deltoid muscle, more...
www.djosurgical.com | Phone: +1-(512)-832-9500, 800-456-8696
FDA Registration: 1644408
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Orthopedic Burr (FDA Code: HTT), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Prosthesis Driver (FDA Code: HWR), ...
Encore Medical, L.P. is a designer, manufacturer and distributor of orthopedic surgery products. Our Reverse® shoulder prosthesis is indicated for use in patients with a functional deltoid muscle, more...
Bradshaw Medical, Inc. | Address: 5732-95th Ave., Suite 100, Kenosha, Wisconsin 53144, USA
www.bradshaw-medical.com | Send Inquiry | Phone: +1-(262)-925-1374
FDA Registration: 3006846753
Products: Screwdrivers & Torques, Ratcheting Screwdriver, Spinal Instrument, Rod Bender, Spinal Instrument, Rod Pusher, Screwdriver (FDA Code: HXX), Spinal Distractors, ...
Bradshaw Medical, Inc specializes in the production of orthopedic and spinal surgical instruments. Our products include spinal instruments, bone awls, probes and sounders. Our spinal instruments are S more...
www.bradshaw-medical.com | Send Inquiry | Phone: +1-(262)-925-1374
FDA Registration: 3006846753
Products: Screwdrivers & Torques, Ratcheting Screwdriver, Spinal Instrument, Rod Bender, Spinal Instrument, Rod Pusher, Screwdriver (FDA Code: HXX), Spinal Distractors, ...
Bradshaw Medical, Inc specializes in the production of orthopedic and spinal surgical instruments. Our products include spinal instruments, bone awls, probes and sounders. Our spinal instruments are S more...
Sandmar Surgical Instruments, Inc. | Address: 9031 58th Place, Kenosha, Wisconsin 53406, USA
Phone: +1-(262)-925-8342
Products: Bone Taps (FDA Code: HWX), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Bending/Contouring Instrument (FDA Code: HXP), Broach (FDA Code: HTQ), ...
Sandmar Surgical Instruments, Inc. deals with ratcheting screwdrivers, torque drivers, silicon fixed handles and adaptors. We also focus on rod & plate benders, bone probes, awls, box chisels, pedicle more...
Phone: +1-(262)-925-8342
Products: Bone Taps (FDA Code: HWX), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Bending/Contouring Instrument (FDA Code: HXP), Broach (FDA Code: HTQ), ...
Sandmar Surgical Instruments, Inc. deals with ratcheting screwdrivers, torque drivers, silicon fixed handles and adaptors. We also focus on rod & plate benders, bone probes, awls, box chisels, pedicle more...
Osteotec Limited | Address: Unit 9, Silver Business Park, Airfield Way, Christchurch, GB-DOR BH23 3TA, United Kingdom 
www.osteotec.co.uk | Send Inquiry | Phone: +44-(01202)-487885
FDA Registration: 3008395366
Products: Awl (FDA Code: HWJ), Broach (FDA Code: HTQ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Screwdriver (FDA Code: HXX), Templates (FDA Code: HWT), Medical Implant Devices, ...
Osteotec Limited is a supplier of medical and surgical products. We are an ISO 9001 and 13485 certified company. Our distal radial fixation provides a modular system of implants that are designed for more...
www.osteotec.co.uk | Send Inquiry | Phone: +44-(01202)-487885
FDA Registration: 3008395366
Products: Awl (FDA Code: HWJ), Broach (FDA Code: HTQ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Screwdriver (FDA Code: HXX), Templates (FDA Code: HWT), Medical Implant Devices, ...
Osteotec Limited is a supplier of medical and surgical products. We are an ISO 9001 and 13485 certified company. Our distal radial fixation provides a modular system of implants that are designed for more...
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FDA Code / Regulation: HTQ / 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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