Surgical Bit Suppliers
Limit companies to: Worldwide USA
Depuy Orthopaedics, Inc. | Address: 4240 Holden Street, Emeryville, California 94608, USA 
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Allografts, Hydroxyapatite, Autologous Platelet Gel Preparation Systems, Disc Replacements, ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Allografts, Hydroxyapatite, Autologous Platelet Gel Preparation Systems, Disc Replacements, ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Orthopedic Cushions, Probes (FDA Code: HXB), Sutures, Old Plating Systems, Compression Hip Screw Systems, Plating Systems, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Orthopedic Cushions, Probes (FDA Code: HXB), Sutures, Old Plating Systems, Compression Hip Screw Systems, Plating Systems, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement 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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
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...
Kirwan Surgical Products | Address: 180 Enterprise Drive, PO Box 427, Marshfield, Massachusetts 02050, USA
www.ksp.com | Send Inquiry | Phone: +1-(781)-834-9500, 888-KIRWANS
FDA Registration: 1219619 Year Established: 1979 Employee Count: ~180 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Bipolar Forceps, Dressing Forceps, Tissue Forceps, Monopolar Aids, Standard, ...
Kirwan Surgical Products manufactures surgical instruments for microsurgical specialties such as neurosurgery, ophthalmology & ear, nose and throat. Our Aura™ line of non-stick forceps offers a more...
www.ksp.com | Send Inquiry | Phone: +1-(781)-834-9500, 888-KIRWANS
FDA Registration: 1219619 Year Established: 1979 Employee Count: ~180 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Bipolar Forceps, Dressing Forceps, Tissue Forceps, Monopolar Aids, Standard, ...
Kirwan Surgical Products manufactures surgical instruments for microsurgical specialties such as neurosurgery, ophthalmology & ear, nose and throat. Our Aura™ line of non-stick forceps offers a 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: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
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: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
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: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
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...
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), Bone Drills, Endoscopic Carpal Tunnel Release Systems, Lavage Systems, Arthroscopes (FDA Code: HRX), Large Bone Battery Power System, ...
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), Bone Drills, Endoscopic Carpal Tunnel Release Systems, Lavage Systems, Arthroscopes (FDA Code: HRX), Large Bone Battery Power System, ...
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...
Minsurg Corporation | Address: 611 Druid Road East, Suite 200, Clearwater, Florida 33756, USA
Phone: +1-(727)-466-4550
FDA Registration: 3005953162
Products: Surgical Bit (FDA Code: GFG), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Reamer (FDA Code: HTO), ...
Minsurg Corporation is a manufacturer of surgical instruments including reamers, holders and inserters. more...
Phone: +1-(727)-466-4550
FDA Registration: 3005953162
Products: Surgical Bit (FDA Code: GFG), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Reamer (FDA Code: HTO), ...
Minsurg Corporation is a manufacturer of surgical instruments including reamers, holders and inserters. 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
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...
Musculoskeletal Transplant Foundation | Address: 125 May St., Suite 300, Edison, New Jersey 08837, USA
www.mtf.org | Send Inquiry | Phone: +1-(732732)-661-0202
FDA Registration: 2249062
Products: Forceps (FDA Code: HTD), Bone Mallets (FDA Code: HXL), Bone Wax (FDA Code: MTJ), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tamps (FDA Code: HXG), ...
Musculoskeletal Transplant Foundation is a provider of allograft tissues. Our sports medicine tissues are available for ligament reconstruction, cartilage repair, and meniscal transplantation. We also more...
www.mtf.org | Send Inquiry | Phone: +1-(732732)-661-0202
FDA Registration: 2249062
Products: Forceps (FDA Code: HTD), Bone Mallets (FDA Code: HXL), Bone Wax (FDA Code: MTJ), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tamps (FDA Code: HXG), ...
Musculoskeletal Transplant Foundation is a provider of allograft tissues. Our sports medicine tissues are available for ligament reconstruction, cartilage repair, and meniscal transplantation. We also 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
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...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
Tedan Surgical Innovations, LLc | Address: 11333, Chimney Rock Road, Suite 180, Houston, Texas 77035, USA
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Small Depth Gauge (FDA Code: HTJ), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, Self-Retaining Retractors (FDA Code: FFO), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Small Depth Gauge (FDA Code: HTJ), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
American Medical Specialties, Inc. | Address: 1207 Business Park Dr, Suite B, Mission, Texas 78572, USA
www.ammeds.com | Send Inquiry | Phone: +1-(727)-561-9400, 800-808-2877
Year Established: 1992 Annual Revenues: USD 1-5 Million Quality: ISO 13485:2003 and CE Mark Certified
Products: Surgical Blades, Drill Bit (FDA Code: HTW), Reciprocating Saw Blades, Oscillating Saw Blades, Sagittal Saw Blades, Saw Blades, ...
American Medical Specialties, Inc. specializes in disposable cutting tools. We offer various types of surgical blades, burs, wires, pins and drills. We provide Zimmer Micro Choice® type, Zimmer ty more...
www.ammeds.com | Send Inquiry | Phone: +1-(727)-561-9400, 800-808-2877
Year Established: 1992 Annual Revenues: USD 1-5 Million Quality: ISO 13485:2003 and CE Mark Certified
Products: Surgical Blades, Drill Bit (FDA Code: HTW), Reciprocating Saw Blades, Oscillating Saw Blades, Sagittal Saw Blades, Saw Blades, ...
American Medical Specialties, Inc. specializes in disposable cutting tools. We offer various types of surgical blades, burs, wires, pins and drills. We provide Zimmer Micro Choice® type, Zimmer ty more...
Instrumed, Inc. | Address: 19495 144th Ave NE #B-210, Woodinville, Washington 98072, USA
www.instrumedinc.com | Send Inquiry | Phone: +1-(425)-486 4340
FDA Registration: 1811755
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Bone Cement Removal Devices, Arthroscopes (FDA Code: HRX), Bone Cement (FDA Code: LOD), Bone Cement Mixing Systems, ...
Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, more...
www.instrumedinc.com | Send Inquiry | Phone: +1-(425)-486 4340
FDA Registration: 1811755
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Bone Cement Removal Devices, Arthroscopes (FDA Code: HRX), Bone Cement (FDA Code: LOD), Bone Cement Mixing Systems, ...
Instrumed, Inc. develops and markets medical devices used during orthopedic surgery of the arms & legs. We manufacture orthopedic surgical equipment, urological stents, urological surgical catheters, more...
Synthes Gmbh | Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
Zimmer Gmbh | Address: Sulzer Allee 8, Winterthur CH-8404, Switzerland
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India 
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
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FDA Code / Regulation: GFG / 878.4820
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
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 878.9.
