Medical Rasps Suppliers
Limit companies to: Worldwide USA
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...
Orthofix Inc. | Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
EBI Patient Care, Inc. | Address: 1 Electro-biology Blvd., Guaynabo 00657, USA
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Phone: +1-(973)-299-9300
FDA Registration: 3003435252
Products: Bone Taps (FDA Code: HWX), Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cast Bandage (FDA Code: ITG), ...
EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage. more...
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have 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...
Seaspine | Address: 2302 La Mirada Drive, Vista, California 92081-7862, USA
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Anterior Cervical Plate, Bone Graft Harvester, General use Surgical Curettes (FDA Code: FZS), Manual Surgical Chisel (FDA Code: FZO), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Anterior Cervical Plate, Bone Graft Harvester, General use Surgical Curettes (FDA Code: FZS), Manual Surgical Chisel (FDA Code: FZO), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
Spine Wave, Inc. | Address: Three Enterprise Drive, Suite 210, Shelton, Connecticut 06484, USA
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Pedicle Screw System, Vertebral Body Replacement System, Medical Devices, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Pedicle Screw System, Vertebral Body Replacement System, Medical Devices, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
R Medical Inc. | Address: 28835 N. Herky Drive, Unit 101, Lake Bluff, Illinois 60044, USA
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources 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...
DE Good Dimensional Concepts, Inc. | Address: 7815 State Route 13 North, North Webster, Indiana 46555, USA
www.degooddimensionalconcepts.com | Phone: +1-(574)-834-5437
Products: Forceps (FDA Code: HTD), Medical Rasps (FDA Code: HTR), Bone Screws, Bone Fixation Plate (FDA Code: HRS), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Battery-Powered Electrosurgical Radiofrequency Cutting Apparatus (FDA Code: NCR), ...
DE Good Dimensional Concepts, Inc. offers precision orthopedic, spinal & trauma implants and instruments. Our instruments include cutting apparatus, tooling, drills, forceps, cutting blocks, gages, re more...
www.degooddimensionalconcepts.com | Phone: +1-(574)-834-5437
Products: Forceps (FDA Code: HTD), Medical Rasps (FDA Code: HTR), Bone Screws, Bone Fixation Plate (FDA Code: HRS), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Battery-Powered Electrosurgical Radiofrequency Cutting Apparatus (FDA Code: NCR), ...
DE Good Dimensional Concepts, Inc. offers precision orthopedic, spinal & trauma implants and instruments. Our instruments include cutting apparatus, tooling, drills, forceps, cutting blocks, gages, re 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: Blade Holders, Arthroscopy, Hook Knife, Arthroscopy, Meniscutome, Acetabular Cup System, Awl (FDA Code: HWJ), Curettes (FDA Code: HTF), ...
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: Blade Holders, Arthroscopy, Hook Knife, Arthroscopy, Meniscutome, Acetabular Cup System, Awl (FDA Code: HWJ), Curettes (FDA Code: HTF), ...
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...
Tornier Inc. | Address: 100 Cummings Center, Suite 444c, Beverly, Massachusetts 01915, USA
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), Bone Fixation Screw (FDA Code: HWC), Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), Bone Fixation Screw (FDA Code: HWC), Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
Pappas Surgical Instruments, LLC | Address: 7 October Hill Rd., Holliston, Massachusetts 01746, USA
Phone: +1-(508)-429-1049
Products: Bone Rasps (FDA Code: HTR), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Orthopedic Osteotome (FDA Code: HWM), Curettes (FDA Code: HTF), ...
Pappas Surgical Instruments, LLC specializes in offering various types of curettes, osteotomes and rasps. more...
Phone: +1-(508)-429-1049
Products: Bone Rasps (FDA Code: HTR), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Orthopedic Osteotome (FDA Code: HWM), Curettes (FDA Code: HTF), ...
Pappas Surgical Instruments, LLC specializes in offering various types of curettes, osteotomes and rasps. more...
Pioneer Surgical Technology | Address: 375 River Park Circle, Marquette, Michigan 49855, USA
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Modular Sternal Cable System, Anterior Cervical Plating System, Surgical Instrument Tray (FDA Code: FSM), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bone Fixation Screw (FDA Code: HWC), Spinal Fixation Device Implant (FDA Code: JDN), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
www.pioneersurgical.com | Send Inquiry | Phone: +1-(906)-226-9909, 800-557-9909
FDA Registration: 1833824 Year Established: 1992 Annual Revenues: USD 25-50 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Modular Sternal Cable System, Anterior Cervical Plating System, Surgical Instrument Tray (FDA Code: FSM), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Bone Fixation Screw (FDA Code: HWC), Spinal Fixation Device Implant (FDA Code: JDN), ...
Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straigh more...
Sterilmed, Inc. | Address: 11400 73rd Ave. North, #100, Maple Grove, Minnesota 55369, USA
www.sterilmed.com | Send Inquiry | Phone: +1-(763)-488-3400, 888-252-1542
FDA Registration: 2134070
Products: Biopsy Forceps, Balloon Inflation Devices, Arthroscopy, Hook Probe, Burs & Drills, Burr, Arthroscopic Shavers, ...
Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-own more...
www.sterilmed.com | Send Inquiry | Phone: +1-(763)-488-3400, 888-252-1542
FDA Registration: 2134070
Products: Biopsy Forceps, Balloon Inflation Devices, Arthroscopy, Hook Probe, Burs & Drills, Burr, Arthroscopic Shavers, ...
Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-own more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Ankle Distractors, General Surgical Instruments, Packaging, Spinal Implants, Medical Diagnostic Imaging, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Ankle Distractors, General Surgical Instruments, Packaging, Spinal Implants, Medical Diagnostic Imaging, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
Ingen Orthopedics Llc | Address: 2650 Us Highway 130, Cranbury, New Jersey 08512, USA
www.ingenortho.com | Send Inquiry | Phone: +1-(609)-4093316
FDA Registration: 3005130928
Products: Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Orthopedic Rasps, Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis (FDA Code: KWS), Templates (FDA Code: HWT), ...
Ingen Orthopedics Llc deals with shoulder prosthesis. Our product line includes primary stem, standard & offset head and glenoid component. more...
www.ingenortho.com | Send Inquiry | Phone: +1-(609)-4093316
FDA Registration: 3005130928
Products: Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Orthopedic Rasps, Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis (FDA Code: KWS), Templates (FDA Code: HWT), ...
Ingen Orthopedics Llc deals with shoulder prosthesis. Our product line includes primary stem, standard & offset head and glenoid component. more...
Custom Spine, Inc. | Address: 1140 Parsippany Blvd., Suite 201, Parsippany, New Jersey 07054, USA
www.customspine.com | Send Inquiry | Phone: +1-(973)-808-0019
Products: Spinal Implants, Anterior Cervical Plate, Cervical Plate System, Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Custom Spine, Inc. develops spinal implants and instrumentations. We focus on the cause of chronic pain in the cervical region which includes cervical disc herniations and stenosis as well as spondylo more...
www.customspine.com | Send Inquiry | Phone: +1-(973)-808-0019
Products: Spinal Implants, Anterior Cervical Plate, Cervical Plate System, Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Custom Spine, Inc. develops spinal implants and instrumentations. We focus on the cause of chronic pain in the cervical region which includes cervical disc herniations and stenosis as well as spondylo 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...
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FDA Code / Regulation: HTR / 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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