Bone Hooks Suppliers
Bone hooks are designed for proximal femoral elevation in total hip replacement or in other surgery with a similar need for bone manipulation. This instrument has a blunt tip and a large handle to accommodate the use of two hands if desired.
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...
HNM Medical | Address: 20855 NE 16 Avenue Suite C15, N. Miami, Florida 33179, USA
www.hnmmedical.com | Send Inquiry | Phone: +1-(866)-291.8498
Annual Revenues: USD 1-5 Million
Products: Bone Cutters, Bone Rongeurs, Bone Holding Forceps, Bone Hooks (FDA Code: KIK), Bone Cutting Forceps, Anterior Cervical Fusion Kit, ...
HNM Medical is a manufacturer and distributor of surgical instruments and other medical supplies. We are an ISO 9001 certified company. Our cardio-thoracic surgical instruments include rib shears, rib more...
www.hnmmedical.com | Send Inquiry | Phone: +1-(866)-291.8498
Annual Revenues: USD 1-5 Million
Products: Bone Cutters, Bone Rongeurs, Bone Holding Forceps, Bone Hooks (FDA Code: KIK), Bone Cutting Forceps, Anterior Cervical Fusion Kit, ...
HNM Medical is a manufacturer and distributor of surgical instruments and other medical supplies. We are an ISO 9001 certified company. Our cardio-thoracic surgical instruments include rib shears, rib more...
Innomed, Inc. | Address: 103 Estus Drive, Savannah, Georgia 31404, USA
www.innomed.net | Send Inquiry | Phone: +1-(912)-236-0000
FDA Registration: 1833053
Products: Curettes, Elevators, Mallets, Retractors, Rongeurs, Self-Retaining Retractors (FDA Code: FFO), ...
Innomed, Inc. produces surgical instruments for orthopaedic surgery. We offer instruments like hip instrument, knee instrument, shoulder & elbow instrument, and spine instrument. We create femoral hea more...
www.innomed.net | Send Inquiry | Phone: +1-(912)-236-0000
FDA Registration: 1833053
Products: Curettes, Elevators, Mallets, Retractors, Rongeurs, Self-Retaining Retractors (FDA Code: FFO), ...
Innomed, Inc. produces surgical instruments for orthopaedic surgery. We offer instruments like hip instrument, knee instrument, shoulder & elbow instrument, and spine instrument. We create femoral hea 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: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
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: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
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...
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...
Kmedic | Address: 190 Veterans Drive, Northvale, New Jersey 07647, USA
www.kmedic.com | Send Inquiry | Phone: +1-(201)-767-4002
FDA Registration: 3012164475 Year Established: 1986 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Curettes, Forceps (FDA Code: HTD), Mallets, Retractors, Scissors, Bone Cutters, ...
Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products l more...
www.kmedic.com | Send Inquiry | Phone: +1-(201)-767-4002
FDA Registration: 3012164475 Year Established: 1986 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Curettes, Forceps (FDA Code: HTD), Mallets, Retractors, Scissors, Bone Cutters, ...
Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products l more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical 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...
C D S Surgical Inc. | Address: 212 Godshall Road, P.O.Box 26291, Collegeville, Pennsylvania 19426-0291, USA
www.cdssurgical.com | Send Inquiry | Phone: +1-(800)-874-7705
Products: Elevators, Bone Cutters, Bone Holding Forceps, Bone Hooks (FDA Code: KIK), Bone Curettes, Incision Scalpels, ...
C D S Surgical Inc. specializes in surgical instruments, hospital supplies and equipment. We provide health care solutions. Our product line includes hook and dissector, dressing forcep, elevators, sc more...
www.cdssurgical.com | Send Inquiry | Phone: +1-(800)-874-7705
Products: Elevators, Bone Cutters, Bone Holding Forceps, Bone Hooks (FDA Code: KIK), Bone Curettes, Incision Scalpels, ...
C D S Surgical Inc. specializes in surgical instruments, hospital supplies and equipment. We provide health care solutions. Our product line includes hook and dissector, dressing forcep, elevators, sc more...
Millennium Surgical Corp. | Address: 822 Montgomery Ave, #205, Narberth, Pennsylvania 19072, USA
www.surgicalinstruments.com | Send Inquiry | Phone: +1-(610)-771.0850
FDA Registration: 3004215117
Products: Autoclaves, Automatic Autoclaves, Adjustable Mastoid Retractor, Arteriotomy Clamp, Aspirators And Accessories, Anterior Cervical Fusion Longitudinal Retractor, ...
Millennium Surgical Corp. deals with surgical instruments of all specialties. Our product range comprises of instrument trays, eye surgical instruments, eye needles & cannulas, diamond knives, eye dra more...
www.surgicalinstruments.com | Send Inquiry | Phone: +1-(610)-771.0850
FDA Registration: 3004215117
Products: Autoclaves, Automatic Autoclaves, Adjustable Mastoid Retractor, Arteriotomy Clamp, Aspirators And Accessories, Anterior Cervical Fusion Longitudinal Retractor, ...
Millennium Surgical Corp. deals with surgical instruments of all specialties. Our product range comprises of instrument trays, eye surgical instruments, eye needles & cannulas, diamond knives, eye dra more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Tissue Forceps, Sinus Trochars and Cannulae, Tourniquets, Vascular Clamps (FDA Code: DXC), Adjustable Bone Holding Forceps, Dilators, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery 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...
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...
Greatbatch Medical, Inc., | Address: 10000 Wehrle Drive, Clarence, New York 14031, USA
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Amputation Saws, Cortical Screws, Dental Implants, Compression Screw, Cancellous Bone Screw, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
www.greatbatchmedical.com | Send Inquiry | Phone: +1-(716)-759-5600
FDA Registration: 3004976965 Quality: ISO 13485 Certified
Products: Blades, Amputation Saws, Cortical Screws, Dental Implants, Compression Screw, Cancellous Bone Screw, ...
Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly more...
Synthes (USA) | Address: 35 Airport Road, Horseheads, New York 14845, USA
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
Aesculap Implant Systems, Inc. | Address: #3773, Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
Smith & Nephew | Address: 15 Adam Street, London WC2N 6LA, United Kingdom 
www.smith-nephew.com/uk | Send Inquiry | Phone: +44-(020)-7401-7646
Year Established: 1856 Annual Revenues: USD 1-5 Million Employee Count: ~320
Products: Curettes, Sutures, Light Sources, Headlight Box / Light source, Tibial Inserts, Patellar Implants, ...
Smith & Nephew develops and markets advanced medical devices. We focus on orthopaedics, endoscopy and advanced wound management. We create new solutions to chronic and acute wound management problems. more...
www.smith-nephew.com/uk | Send Inquiry | Phone: +44-(020)-7401-7646
Year Established: 1856 Annual Revenues: USD 1-5 Million Employee Count: ~320
Products: Curettes, Sutures, Light Sources, Headlight Box / Light source, Tibial Inserts, Patellar Implants, ...
Smith & Nephew develops and markets advanced medical devices. We focus on orthopaedics, endoscopy and advanced wound management. We create new solutions to chronic and acute wound management problems. more...
JMF (T) Group Co., Ltd. | Address: 75/74 Moo 11, Paholyothin Rd., Klongnueng, Klongluang, Pathunthanee, TH-13 12120, Thailand
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
JMF (T) Group Co., Ltd. specializes in manufacturing OEM medical devices. We provide large & small fragment implants and instruments. We also offer surgical power tools, sterile container systems, max more...
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
JMF (T) Group Co., Ltd. specializes in manufacturing OEM medical devices. We provide large & small fragment implants and instruments. We also offer surgical power tools, sterile container systems, max more...
Synthes Gmbh | Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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...
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FDA Code / Regulation: KIK / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
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 878.9.
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