Instrument Surgical Guide Suppliers
Limit companies to: Worldwide USA
Safewire LLC | Address: 8963 Stirling Road, Suite 7, Cooper City, Florida 33328, USA 
www.safe-wire.com | Phone: +1-(800)-286-9155
Products: Orthopedics Accessory Instruments, Orthopedics Instruments, Orthopedic Instruments, Instrument Surgical Guide (FDA Code: FZX), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Safewire LLC is a supplier of spinal and orthopedic instruments. We offer cannulated spinal instruments and implants. more...
www.safe-wire.com | Phone: +1-(800)-286-9155
Products: Orthopedics Accessory Instruments, Orthopedics Instruments, Orthopedic Instruments, Instrument Surgical Guide (FDA Code: FZX), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Safewire LLC is a supplier of spinal and orthopedic instruments. We offer cannulated spinal instruments and implants. 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: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
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: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Invivo | Address: 12501 Research Parkway, Orlando, Florida 32826, USA
www.invivocorp.com | Send Inquiry | Phone: +1-(407)-275-3220, 800-331-3220
FDA Registration: 1056069 Year Established: 1987 Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Electrosurgery, General Medical Supplies, Pulse Oximeters, ...
Invivo specializes in MRI monitoring, which provides accurate vital signs for improved patient safety. Our 4500 MRI pulse oximeter uses advanced fiberoptic technology to provide accurate SpO2 readings more...
www.invivocorp.com | Send Inquiry | Phone: +1-(407)-275-3220, 800-331-3220
FDA Registration: 1056069 Year Established: 1987 Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Electrosurgery, General Medical Supplies, Pulse Oximeters, ...
Invivo specializes in MRI monitoring, which provides accurate vital signs for improved patient safety. Our 4500 MRI pulse oximeter uses advanced fiberoptic technology to provide accurate SpO2 readings more...
Inion, Inc. | Address: 2800 Glades Circle, Suite 138, Weston, Florida 33327, USA
www.inion.com | Send Inquiry | Phone: +1-(954)-659-9224
FDA Registration: 3003547707 Year Established: 2000
Products: Hand Instruments, Surgical Trays (FDA Code: LRP), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
Inion, Inc. is a medical device company that focuses on the development and commercialization of biodegradable & bioactive implants. Our products include biodegradable plates, screws, pins and membran more...
www.inion.com | Send Inquiry | Phone: +1-(954)-659-9224
FDA Registration: 3003547707 Year Established: 2000
Products: Hand Instruments, Surgical Trays (FDA Code: LRP), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
Inion, Inc. is a medical device company that focuses on the development and commercialization of biodegradable & bioactive implants. Our products include biodegradable plates, screws, pins and membran 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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
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...
TL Tate Mfg, Inc. | Address: 1500 N Webster Street, Kokomo, Indiana 46901, USA
www.tltate.com | Send Inquiry | Phone: +1-(765)-452-8283
Annual Revenues: < USD 1 Million Quality: ISO, CE Certified
Products: Expanded Mesh Skin Graft Cutter, General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Instrument Surgical Guide (FDA Code: FZX), ...
TL Tate Mfg, Inc. offers operating room tools and surgical instruments. more...
www.tltate.com | Send Inquiry | Phone: +1-(765)-452-8283
Annual Revenues: < USD 1 Million Quality: ISO, CE Certified
Products: Expanded Mesh Skin Graft Cutter, General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Instrument Surgical Guide (FDA Code: FZX), ...
TL Tate Mfg, Inc. offers operating room tools and surgical instruments. more...
Symmetry Medical USA, Inc. | Address: 486 West 350 North, Warsaw, Indiana 46582, USA
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
www.symmetrymedical.com/Products/Instruments/Default.aspx | Phone: +1-(574)-267-8700
FDA Registration: 1828464 Employee Count: ~1800
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Ophthalmology Forceps, Dissectors, Gastroenterologic Needle Holder (FDA Code: FHQ), Blade Holders, ...
Symmetry Medical USA, Inc. provides implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce products for companies in the arthroscopy, dental, laparosco more...
Aptis Medical, LLC. | Address: 3602 Glenview Ave, Glenview, Kentucky 40025, USA
www.aptismedical.com | Send Inquiry | Phone: +1-(502)-523-6738
FDA Registration: 3004521401
Products: Surgical Trays (FDA Code: LRP), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Nail Extractors (FDA Code: HWB), Flexible Depth Gauge (FDA Code: HTJ), ...
Aptis Medical, LLC. develops distal radial ulna. Our product distal radial ulna includes radial plate with socket, UHMW polyethylene ball, cover with two screws & ulna stem with distal peg. It reduces more...
www.aptismedical.com | Send Inquiry | Phone: +1-(502)-523-6738
FDA Registration: 3004521401
Products: Surgical Trays (FDA Code: LRP), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Nail Extractors (FDA Code: HWB), Flexible Depth Gauge (FDA Code: HTJ), ...
Aptis Medical, LLC. develops distal radial ulna. Our product distal radial ulna includes radial plate with socket, UHMW polyethylene ball, cover with two screws & ulna stem with distal peg. It reduces 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: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
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: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
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...
Boston Scientific Corporation | Address: One Boston Scientific Place, Natick, Massachusetts 01760-1537, USA
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Coronary Dilation Balloons, Compliant, Coronary Perfusion Balloons, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Coronary Dilation Balloons, Compliant, Coronary Perfusion Balloons, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
Holmed Corporation | Address: 40 Norfolk Avenue, South Easton, Massachusetts 2375, USA
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
www.holmed.net | Send Inquiry | Phone: +1-(508)-238-3351
FDA Registration: 1219518 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Bone Awls and Probes, ...
Holmed Corporation deals with the design and manufacture of orthopedic products. Our expertise includes the design & manufacture of hip, knee, shoulder, elbow, & spine instruments and spinal implants. more...
Stat Instruments, LLC | Address: 65 Winter Street, Weymouth, Massachusetts 02188, USA
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Bone Clamp (FDA Code: HXD), Surgical Instrument Tray (FDA Code: FSM), Instrument Surgical Guide (FDA Code: FZX), Bone Trephine (FDA Code: HWK), ...
Stat Instruments, LLC is a provider of bone clamps, drill bits and surgical instrument trays. more...
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Bone Clamp (FDA Code: HXD), Surgical Instrument Tray (FDA Code: FSM), Instrument Surgical Guide (FDA Code: FZX), Bone Trephine (FDA Code: HWK), ...
Stat Instruments, LLC is a provider of bone clamps, drill bits and surgical instrument trays. more...
INRAD | Address: 4375 Donker Court S.E., Kentwood, Michigan 49512, USA
www.inradinc.com | Send Inquiry | Phone: +1-(616)-301-7800, 800-558-4647
FDA Registration: 1835568 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Implantable Venous Access Catheter Introducer Kits, ...
Inrad is a developer, manufacturer and distributor of medical devices serving the radiology & biopsy markets. We help to reduce the uncertainty in diagnosis by creating devices that offer more precisi more...
www.inradinc.com | Send Inquiry | Phone: +1-(616)-301-7800, 800-558-4647
FDA Registration: 1835568 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Implantable Venous Access Catheter Introducer Kits, ...
Inrad is a developer, manufacturer and distributor of medical devices serving the radiology & biopsy markets. We help to reduce the uncertainty in diagnosis by creating devices that offer more precisi 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: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
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: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
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...
Biopro, Inc. | Address: 17 Seventeenth St., Port Huron, Michigan 48060, USA
www.bioproimplants.com | Send Inquiry | Phone: +1-(810)-982-7777, 800-252-7707
FDA Registration: 1833506 Year Established: 1987 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Subtalar Implant System, Shoulder joint Prosthesis, Instrument Surgical Guide (FDA Code: FZX), Bone Fixation Screw (FDA Code: HWC), Bone Fixation Staple (FDA Code: JDR), Carpal Trapezium Wrist Prosthesis (FDA Code: KYI), ...
Biopro, Inc. designs, manufactures, and distributes orthopedic products & surgical devices. Our product line includes lower extremities, upper extremities, hip and knee replacement products. The BioPr more...
www.bioproimplants.com | Send Inquiry | Phone: +1-(810)-982-7777, 800-252-7707
FDA Registration: 1833506 Year Established: 1987 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Subtalar Implant System, Shoulder joint Prosthesis, Instrument Surgical Guide (FDA Code: FZX), Bone Fixation Screw (FDA Code: HWC), Bone Fixation Staple (FDA Code: JDR), Carpal Trapezium Wrist Prosthesis (FDA Code: KYI), ...
Biopro, Inc. designs, manufactures, and distributes orthopedic products & surgical devices. Our product line includes lower extremities, upper extremities, hip and knee replacement products. The BioPr more...
Lake Region Manufacturing, Inc. | Address: 340 Lake Hazeltine Dr., Chaska, Minnesota 55318-1034, USA
www.lakergn.com | Send Inquiry | Phone: +1-(952)-448-5111
FDA Registration: 2126666 Quality: ISO 9001 Certified
Products: Phacoemulsification Systems, Diagnostic Guidewires, Steerable, Ultrasonic Phacoemulsification System, Compact Phacoemulsification Systems, Nephrostomy Catheter (FDA Code: LJE), Percutaneous Catheter (FDA Code: DQY), ...
Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applic more...
www.lakergn.com | Send Inquiry | Phone: +1-(952)-448-5111
FDA Registration: 2126666 Quality: ISO 9001 Certified
Products: Phacoemulsification Systems, Diagnostic Guidewires, Steerable, Ultrasonic Phacoemulsification System, Compact Phacoemulsification Systems, Nephrostomy Catheter (FDA Code: LJE), Percutaneous Catheter (FDA Code: DQY), ...
Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applic 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), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
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), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
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...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Bone Taps (FDA Code: HWX), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Bone Taps (FDA Code: HWX), ...
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, Drills, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Catheter Introducers (FDA Code: DYB), Interference Screws, ...
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, Drills, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Catheter Introducers (FDA Code: DYB), Interference Screws, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
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FDA Code / Regulation: FZX / 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.
