General & Plastic Surgery Surgical Burr 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: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
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: Curettes, Manipulators, Rotators, Spatulas and Picks, Lacrimal Dilators and Cannulas, Fixation Rings, Vannas Capsulotomy Scissors, Intraocular Lens Manipulators, ...
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...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Arthrex, Inc. | Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
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: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
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: 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...
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: Bipolar Forceps, Monopolar Aids, Standard, Reusable Bipolar Forceps, Microsurgical Bipolar Forceps, Titanium Bipolar Forceps (Ophthalmology), ...
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: Bipolar Forceps, Monopolar Aids, Standard, Reusable Bipolar Forceps, Microsurgical Bipolar Forceps, Titanium Bipolar Forceps (Ophthalmology), ...
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...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
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: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
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: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
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: 80° Vertical Microscissors, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Active Electrosurgical Electrode (FDA Code: FAS), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
www.conmed.com | Send Inquiry | Phone: +1-(315)-797-8375
FDA Registration: 1223925 Year Established: 1970 Employee Count: ~2300
Products: 80° Vertical Microscissors, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Active Electrosurgical Electrode (FDA Code: FAS), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Conmed Corporation specializes in the fields of gastroenterology & pulmonology. Our bite block's patented integral tongue depressor offers easier esophageal intubation with direct visualization & decr more...
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...
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: MP Joint Implants, Hammertoe Implants, Foot Fragment Sets, Mini Lag Screw Systems, Cannulated Screw System, Cannulated Screw Fracture Fixation System, ...
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: MP Joint Implants, Hammertoe Implants, Foot Fragment Sets, Mini Lag Screw Systems, Cannulated Screw System, Cannulated Screw Fracture Fixation System, ...
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), 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...
Ditec Mfg. | Address: 1019 Mark Avenue, Carpinteria, California 93013, USA
www.ditecmfg.com | Send Inquiry | Phone: +1-(805)-566-7800, 800-332-7083
Year Established: 1985 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9002 Certified
Products: Medical Instruments, Procedure Kits, General & Plastic Surgery Surgical Burr (FDA Code: GFF), Drug Administration Medical Devices, Surgical Cutting Instruments, Precision Diamond Burs, Surgical Burs, ...
Ditec Mfg. is a contract manufacturer of precision diamond burs, surgical burs, medical and dental instruments, tools, supplies & components. We also produce dependable climbing and retrieval equipmen more...
www.ditecmfg.com | Send Inquiry | Phone: +1-(805)-566-7800, 800-332-7083
Year Established: 1985 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO 9002 Certified
Products: Medical Instruments, Procedure Kits, General & Plastic Surgery Surgical Burr (FDA Code: GFF), Drug Administration Medical Devices, Surgical Cutting Instruments, Precision Diamond Burs, Surgical Burs, ...
Ditec Mfg. is a contract manufacturer of precision diamond burs, surgical burs, medical and dental instruments, tools, supplies & components. We also produce dependable climbing and retrieval equipmen more...
Lasco Diamond Products | Address: 9950 Canoga Avenue, Unit A-8, PO Box 4657, Chatsworth, California 91311-6703, USA
www.lascodiamond.com | Send Inquiry | Phone: +1-(818)-882-2423, 800-621-4726
FDA Registration: 2020356 Year Established: 1963 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: General & Plastic Surgery Surgical Burr (FDA Code: GFF), Burr, ...
Lasco Diamond Products is a provider of diamond instruments for dental and cosmetology industries. Our dental products include operator diamond burs, finishing diamond burs, laboratory diamond & carbi more...
www.lascodiamond.com | Send Inquiry | Phone: +1-(818)-882-2423, 800-621-4726
FDA Registration: 2020356 Year Established: 1963 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: General & Plastic Surgery Surgical Burr (FDA Code: GFF), Burr, ...
Lasco Diamond Products is a provider of diamond instruments for dental and cosmetology industries. Our dental products include operator diamond burs, finishing diamond burs, laboratory diamond & carbi more...
Dentsply Caulk | Address: 38 W. Clarke Avenue, Milford, Delaware 19963, USA
www.caulk.com | Send Inquiry | Phone: +1-(800)-532-2855
FDA Registration: 2515379 Year Established: 1877 Annual Revenues: USD 50-100 Million Employee Count: ~9400 Quality: ISO 9000, ISO 9001, CE Certified
Products: General Medical Supplies, General Surgery Supplies, X-Ray Accessories, Leaded Aprons (FDA Code: EAJ), Flexible Padded Abdominal Retractor, Liquid Medication Dispenser (FDA Code: KYX), Endoscope Cleaning Brushes & Accessories (FDA Code: MNL), ...
Dentsply Caulk offers dental products. Our product categories are alloys & accessories, bone grafting materials, burs, cements & liners, impression materials, irrigation probes, and x-ray products. Ou more...
www.caulk.com | Send Inquiry | Phone: +1-(800)-532-2855
FDA Registration: 2515379 Year Established: 1877 Annual Revenues: USD 50-100 Million Employee Count: ~9400 Quality: ISO 9000, ISO 9001, CE Certified
Products: General Medical Supplies, General Surgery Supplies, X-Ray Accessories, Leaded Aprons (FDA Code: EAJ), Flexible Padded Abdominal Retractor, Liquid Medication Dispenser (FDA Code: KYX), Endoscope Cleaning Brushes & Accessories (FDA Code: MNL), ...
Dentsply Caulk offers dental products. Our product categories are alloys & accessories, bone grafting materials, burs, cements & liners, impression materials, irrigation probes, and x-ray products. Ou more...
Mekanika, Inc. | Address: 3998 Fau Blvd., Suite 210, Boca Raton, Florida 33431, USA
Phone: +1-(561)-417-7244
Products: Drill Bit (FDA Code: HTW), Drill Bits & Bone Taps, Cannulated Drill Bit, General & Plastic Surgery Surgical Burr (FDA Code: GFF), AC-Powered Dynamometer (FDA Code: LBB), ...
Mekanika, Inc. are providers of spinal stiffness gauges and bone drill bits. more...
Phone: +1-(561)-417-7244
Products: Drill Bit (FDA Code: HTW), Drill Bits & Bone Taps, Cannulated Drill Bit, General & Plastic Surgery Surgical Burr (FDA Code: GFF), AC-Powered Dynamometer (FDA Code: LBB), ...
Mekanika, Inc. are providers of spinal stiffness gauges and bone drill bits. more...
Biomet 3i LLC | Address: 4555 Riverside Dr., Palm Beach Gardens, Florida 33410, USA
www.biomet3i.com | Send Inquiry | Phone: +1-(561)-776-6700, 800-342-5454
FDA Registration: 1038806 Quality: CE Certified
Products: Dental Implants, Bone Mill (FDA Code: LYS), General & Plastic Surgery Surgical Burr (FDA Code: GFF), ...
Biomet 3i LLC offers dentistry's implants and abutments. We develop biological driven implants, for the microtextured surface and superior clinical success rates of the Osseotite® implant. Our den more...
www.biomet3i.com | Send Inquiry | Phone: +1-(561)-776-6700, 800-342-5454
FDA Registration: 1038806 Quality: CE Certified
Products: Dental Implants, Bone Mill (FDA Code: LYS), General & Plastic Surgery Surgical Burr (FDA Code: GFF), ...
Biomet 3i LLC offers dentistry's implants and abutments. We develop biological driven implants, for the microtextured surface and superior clinical success rates of the Osseotite® implant. Our den more...
Raja Trading Company, Inc. | Address: 801 South Olive Ave., Ste. 124, West Palm Bch, Florida 33401, USA
Phone: +1-(561)-868-4600
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Dermabrasion Brush (FDA Code: GFE), General & Plastic Surgery Surgical Burr (FDA Code: GFF), ...
Raja Trading Company, Inc. manufactures surgical products. We supply medical products that include AC powered surgical instrument motors, dermabrasion brushes, general & plastic surgery surgical burrs more...
Phone: +1-(561)-868-4600
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Dermabrasion Brush (FDA Code: GFE), General & Plastic Surgery Surgical Burr (FDA Code: GFF), ...
Raja Trading Company, Inc. manufactures surgical products. We supply medical products that include AC powered surgical instrument motors, dermabrasion brushes, general & plastic surgery surgical burrs more...
Tava Surgical Instruments | Address: One Brasseler Boulevard, Savannah, Georgia 31419, USA
www.tavasurgical.com | Send Inquiry | Phone: +1-(912)-921-7575
FDA Registration: 2025102 Year Established: 1977 Quality: ISO-13485 and CE Mark Certified
Products: Handpieces, Oscillating Saw Blades, General & Plastic Saw Surgical Blade (FDA Code: GFA), General & Plastic Surgery Surgical Burr (FDA Code: GFF), Burr, AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
Tava Surgical Instruments offers rotary cutting instruments for dental and medical industries. We develop a line of surgical power accessories that include both rotary cutters and surgical saw blades more...
www.tavasurgical.com | Send Inquiry | Phone: +1-(912)-921-7575
FDA Registration: 2025102 Year Established: 1977 Quality: ISO-13485 and CE Mark Certified
Products: Handpieces, Oscillating Saw Blades, General & Plastic Saw Surgical Blade (FDA Code: GFA), General & Plastic Surgery Surgical Burr (FDA Code: GFF), Burr, AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
Tava Surgical Instruments offers rotary cutting instruments for dental and medical industries. We develop a line of surgical power accessories that include both rotary cutters and surgical saw blades more...
Zoll Dental | Address: 7450 North Natchez Ave., Niles, Illinois 60714, USA
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Scissors, Dental Forceps, orthodontic pliers, Dental Devices, Dental Bone File, Tissue Pliers, ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
www.zolldental.com | Send Inquiry | Phone: +1-(847)-647-1819
FDA Registration: 1422507
Products: Scissors, Dental Forceps, orthodontic pliers, Dental Devices, Dental Bone File, Tissue Pliers, ...
Zoll Dental manufactures dental hand instruments. We provide re-tipping and re-sharpening services. Our products include dressing pliers, mirror handles, perio/hygiene instruments, operative instrumen more...
Sponsored Links
FDA Code / Regulation: GFF / 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.
