Orthopedic Burr Suppliers
Limit companies to: Worldwide USA
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...
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...
Brasseler USA | Address: 1 Brasseler Boulevard, Savannah, Georgia 31419, USA
www.brasselerusamedical.com | Send Inquiry | Phone: +1-(800)-535-6638
FDA Registration: 2025102 Year Established: 1987 Employee Count: ~150 Quality: ISO, CE Certified
Products: Pneumatic Neurosurgical Drill Systems, Large Bone Battery Power System, Small Bone Pneumatic Power Systems, High Speed Drills, Small Bone Electric Power Systems, Orthopedics, High Speed Drills System, ...
Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sel more...
www.brasselerusamedical.com | Send Inquiry | Phone: +1-(800)-535-6638
FDA Registration: 2025102 Year Established: 1987 Employee Count: ~150 Quality: ISO, CE Certified
Products: Pneumatic Neurosurgical Drill Systems, Large Bone Battery Power System, Small Bone Pneumatic Power Systems, High Speed Drills, Small Bone Electric Power Systems, Orthopedics, High Speed Drills System, ...
Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sel more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
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...
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...
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...
MicroAire Surgical Instruments LLC. | Address: 1641 Edlich Drive, Charlottesville, Virginia 22911, USA
www.microaire.com | Send Inquiry | Phone: +1-(434)-975-8000, 800-722-0822
Annual Revenues: USD 25-50 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Saws (FDA Code: HSO), Endoscopic Carpal Tunnel Release Systems, Lavage Systems, Large Bone Battery Power System, Large Bone Electric Power Systems, Large Bone Pneumatic Power Systems, ...
MicroAire Surgical Instruments LLC. provides innovative surgical solutions for improving surgeon and patient outcomes. Our product categories are power instruments, disposables, pulse lavage, carpal t more...
www.microaire.com | Send Inquiry | Phone: +1-(434)-975-8000, 800-722-0822
Annual Revenues: USD 25-50 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Saws (FDA Code: HSO), Endoscopic Carpal Tunnel Release Systems, Lavage Systems, Large Bone Battery Power System, Large Bone Electric Power Systems, Large Bone Pneumatic Power Systems, ...
MicroAire Surgical Instruments LLC. provides innovative surgical solutions for improving surgeon and patient outcomes. Our product categories are power instruments, disposables, pulse lavage, carpal t 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...
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...
SIM Medical Sales | Address: PO BOX 895, Warsaw, Indiana 46580, USA
www.simmedicalsales.com | Send Inquiry | Phone: +1-(219)-574-268-0341
Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Drill Bit (FDA Code: HTW), Drill Bits & Bone Taps, Cannulated Drill Bit, Burr, Cranial Burr, Bone Cutting Blade, ...
SIM Medical Sales specializes in titanium distraction screw pins and oscillating blades. The titanium distraction screw pins have the ability of self-tapping and its cutting thread design offers easie more...
www.simmedicalsales.com | Send Inquiry | Phone: +1-(219)-574-268-0341
Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Drill Bit (FDA Code: HTW), Drill Bits & Bone Taps, Cannulated Drill Bit, Burr, Cranial Burr, Bone Cutting Blade, ...
SIM Medical Sales specializes in titanium distraction screw pins and oscillating blades. The titanium distraction screw pins have the ability of self-tapping and its cutting thread design offers easie more...
Spinefrontier, Inc. | Address: 500 Cummings Center, Suite 3500, Beverly, Massachusetts 01915, USA
www.spinefrontier.com | Send Inquiry | Phone: +1-(978)-2323990
FDA Registration: 3005977257
Products: Rehabilitation Aids, Diagnostic Equipment, Instrument for Spine Surgery, Facet Screw Spinal Device System (FDA Code: MRW), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Spinefrontier, Inc. provides services for operative instruments, medical devices, diagnostic equipments and rehabilitation aids used in the treatment of spinal diseases. We produce devices and instrum more...
www.spinefrontier.com | Send Inquiry | Phone: +1-(978)-2323990
FDA Registration: 3005977257
Products: Rehabilitation Aids, Diagnostic Equipment, Instrument for Spine Surgery, Facet Screw Spinal Device System (FDA Code: MRW), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), ...
Spinefrontier, Inc. provides services for operative instruments, medical devices, diagnostic equipments and rehabilitation aids used in the treatment of spinal diseases. We produce devices and instrum more...
Hydrocision, Inc. | Address: 22 Linnell Circle, Suite 102, Billerica, Massachusetts 1821, USA
www.hydrocision.com | Send Inquiry | Phone: +1-(888)-747-4470
FDA Registration: 1226424 Year Established: 1996 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Arthroscopes (FDA Code: HRX), Disposable Surgical Instrument (FDA Code: KDC), Water Jet Lavage Unit (FDA Code: FQH), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Orthopedic Burr (FDA Code: HTT), ...
Hydrocision, Inc. deals with hydrosurgery. Hydrocision is our registered trademark. Our HydroCision SpineJet XL accesses entire disc space and removes 95% more contralateral nucleus than conventio more...
www.hydrocision.com | Send Inquiry | Phone: +1-(888)-747-4470
FDA Registration: 1226424 Year Established: 1996 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Arthroscopes (FDA Code: HRX), Disposable Surgical Instrument (FDA Code: KDC), Water Jet Lavage Unit (FDA Code: FQH), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Orthopedic Burr (FDA Code: HTT), ...
Hydrocision, Inc. deals with hydrosurgery. Hydrocision is our registered trademark. Our HydroCision SpineJet XL accesses entire disc space and removes 95% more contralateral nucleus than conventio 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...
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...
Medisiss | Address: 2747 Sw 6th Street, Redmond, Oregon 97756, USA
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
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FDA Code / Regulation: HTT / 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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