General & Plastic Saw Surgical Blade Suppliers
Limit companies to: Worldwide USA
Sontec Instruments, Inc. | Address: 7248 South Tucson Way, Colorado 80112, USA 
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Speculums, Biopsy Capsules & Punches, Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
www.sontecinstruments.com | Send Inquiry | Phone: +1-(303)-790-9411
FDA Registration: 1720747 Employee Count: ~20
Products: Speculums, Biopsy Capsules & Punches, Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, ...
Sontec Instruments, Inc. supplies surgical instrumentation to the medical industry. We deliver a complete line of surgical instruments for cardiovascular/thoracic, urological, gynecological/obstetrica more...
Arthrex, Inc. | Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Interference Screws, Small Joint Arthroscopy Instruments, Small Joint Arthroscopy Instrument Sets, Endoscopic Carpal Tunnel Release Systems, Leg Positioners, Arthroscopes (FDA Code: HRX), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo more...
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Interference Screws, Small Joint Arthroscopy Instruments, Small Joint Arthroscopy Instrument Sets, Endoscopic Carpal Tunnel Release Systems, Leg Positioners, Arthroscopes (FDA Code: HRX), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo 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: Blades, Drills, Saws (FDA Code: HSO), Pneumatic Neurosurgical Drill Systems, Handpieces, Large Bone Battery Power 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: Blades, Drills, Saws (FDA Code: HSO), Pneumatic Neurosurgical Drill Systems, Handpieces, Large Bone Battery Power 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...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l 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, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
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, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
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: 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...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Otoscopes, Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Laryngoscopes, Lacrimal Dilators and Cannulas, Dressing Forceps, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Otoscopes, Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Laryngoscopes, Lacrimal Dilators and Cannulas, Dressing Forceps, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Whiteside Biomechanics, Inc. | Address: 1000 Des Peres Road, Suite 140, St. Louis, Missouri 63131, USA
www.whitesidebio.com | Send Inquiry | Phone: +1-(314)-775-0518, 800-246-6324
Year Established: 1992 Annual Revenues: USD 1-5 Million Quality: ISO 9001, CE Certified
Products: Femoral Components, Acetabular Liners, Revision Femoral Implants, Primary Femoral Implants, Hip Positioner Systems, Osteotomes, ...
Whiteside Biomechanics, Inc. offers a variety of effective hip & knee products. Our quatroloc femoral system is composed of primary, revision and fracture stems to the surgical instrumentation that cr more...
www.whitesidebio.com | Send Inquiry | Phone: +1-(314)-775-0518, 800-246-6324
Year Established: 1992 Annual Revenues: USD 1-5 Million Quality: ISO 9001, CE Certified
Products: Femoral Components, Acetabular Liners, Revision Femoral Implants, Primary Femoral Implants, Hip Positioner Systems, Osteotomes, ...
Whiteside Biomechanics, Inc. offers a variety of effective hip & knee products. Our quatroloc femoral system is composed of primary, revision and fracture stems to the surgical instrumentation that cr more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision 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: Audiometers & Tympanometers, Otoscopes, Forceps (FDA Code: HTD), Scissors, Bipolar Cautery Systems, Monopolar Cautery Systems, ...
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: Audiometers & Tympanometers, Otoscopes, Forceps (FDA Code: HTD), Scissors, Bipolar Cautery Systems, Monopolar Cautery Systems, ...
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...
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...
Miltex, Inc. | Address: 589 Davies Drive, York, Pennsylvania 17402, USA
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Stethoscopes, Pelvimeters, Vaginal Retractors (FDA Code: HDL), Tonometers, Autoclaves, Curettes, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin more...
www.miltex.com | Send Inquiry | Phone: +1-(717)-840-9335
FDA Registration: 2523190 Year Established: 1950 Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Stethoscopes, Pelvimeters, Vaginal Retractors (FDA Code: HDL), Tonometers, Autoclaves, Curettes, ...
Miltex, Inc. specializes in surgical and dental instruments. Our product line includes surgical, dental, gynecology, animal health, podiatry and repair instruments. Our Miltex® endometrial samplin 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...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
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...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Osteomed Corp | Address: 3885 Arapaho Road, Addison, Texas 75001, USA
www.osteomedcorp.com | Send Inquiry | Phone: +1-(972)-677-4600
FDA Registration: 2027754 Year Established: 2002 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO Certified
Products: Forceps (FDA Code: HTD), MP Joint Implants, Hammertoe Implants, Bone Rasps (FDA Code: HTR), Foot Fragment Sets, Mini Lag Screw Systems, ...
Osteomed Corp is a global manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments. We provide the surgeon with innovative products and state of the a more...
www.osteomedcorp.com | Send Inquiry | Phone: +1-(972)-677-4600
FDA Registration: 2027754 Year Established: 2002 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO Certified
Products: Forceps (FDA Code: HTD), MP Joint Implants, Hammertoe Implants, Bone Rasps (FDA Code: HTR), Foot Fragment Sets, Mini Lag Screw Systems, ...
Osteomed Corp is a global manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments. We provide the surgeon with innovative products and state of the a 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...
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FDA Code / Regulation: GFA / 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.
