Orthopedic Cutting Instrument Suppliers
Limit companies to: Worldwide USA
Ortho Medical GmbH Implants | Address: Hauptstr. 5, DA¼rbheim 78589, Germany 
Phone: 074-24-94034
FDA Registration: 9617257
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
Ortho Medical GmbH Implants offers orthopedic instruments, fixation accessory drill bits, scissors, screw drivers, retractors, plastic surgery products, spatulas, rongeurs and chisels. more...
Phone: 074-24-94034
FDA Registration: 9617257
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
Ortho Medical GmbH Implants offers orthopedic instruments, fixation accessory drill bits, scissors, screw drivers, retractors, plastic surgery products, spatulas, rongeurs and chisels. more...
Rema Medizintechnik Gmbh | Address: In Breiten 10, Duerbheim / Tuttlingen D-78589, Germany
www.rema-surgery.de | Send Inquiry | Phone: +49-(7424)-981053-0
Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Suction Tubes, Gastroenterologic Needle Holder (FDA Code: FHQ), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, Arthroscopes (FDA Code: HRX), ...
Rema Medizintechnik Gmbh is a developer, manufacturer and distributor of instruments & equipment for endoscopy, arthroscopy, laparoscopy, thoracoscopy, gynecology and urology. The excaliber arthroscop more...
www.rema-surgery.de | Send Inquiry | Phone: +49-(7424)-981053-0
Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Suction Tubes, Gastroenterologic Needle Holder (FDA Code: FHQ), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, Arthroscopes (FDA Code: HRX), ...
Rema Medizintechnik Gmbh is a developer, manufacturer and distributor of instruments & equipment for endoscopy, arthroscopy, laparoscopy, thoracoscopy, gynecology and urology. The excaliber arthroscop more...
Gebrueder Zepf Medizintechnik | Address: Lehrstr. 11, Durbheim - Tuttlingen D- 78589, Germany
www.gz-medizintechnik.com | Send Inquiry | Phone: +49-(7424)-9572-0
FDA Registration: 8010343 Year Established: 1949
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Rib Rongeurs (FDA Code: HTX), Laser Power Probe, Laparoscopic Probes, Periodontal Probes, ...
Gebrueder Zepf Medizintechnik deals with surgical instruments. Our product list comprises of bone cutting forceps, ear forceps, retractors, biopsy forceps, eye magnet and bone shears. more...
www.gz-medizintechnik.com | Send Inquiry | Phone: +49-(7424)-9572-0
FDA Registration: 8010343 Year Established: 1949
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Rib Rongeurs (FDA Code: HTX), Laser Power Probe, Laparoscopic Probes, Periodontal Probes, ...
Gebrueder Zepf Medizintechnik deals with surgical instruments. Our product list comprises of bone cutting forceps, ear forceps, retractors, biopsy forceps, eye magnet and bone shears. more...
Rudolf Storz Gmbh | Address: Friedrich-WA¶hler-Str. 13, Emmingen-Liptingen 78576, Germany
Phone: +49-(746)-5 920 720
FDA Registration: 9611274
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Wire Twisters (FDA Code: HXS), Tongue Depressors (FDA Code: FMA), Flavored Tongue Depressors, ...
Rudolf Storz Gmbh provides rasp, surgical, general, & plastic surgery trephine, dissector, bone, skin pressure protector, screwdriver, stripper, knife, surgical measuring tape, scoop, nasal spatula, c more...
Phone: +49-(746)-5 920 720
FDA Registration: 9611274
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Wire Twisters (FDA Code: HXS), Tongue Depressors (FDA Code: FMA), Flavored Tongue Depressors, ...
Rudolf Storz Gmbh provides rasp, surgical, general, & plastic surgery trephine, dissector, bone, skin pressure protector, screwdriver, stripper, knife, surgical measuring tape, scoop, nasal spatula, c more...
Rudolf Medical Gmbh + Co. Kg | Address: No. 1 Zollerstr, Fridingen 78567, Germany
www.rudolf-med.com | Phone: +49-(049)-7463-99560
FDA Registration: 8010298
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes an more...
www.rudolf-med.com | Phone: +49-(049)-7463-99560
FDA Registration: 8010298
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes an more...
Allgaier Instrumente Gmbh | Address: Teuchelgrube 6-10, Frittlingen/Tuttlingen D-78665, Germany
www.allgaier-instrumente.de | Send Inquiry | Phone: +49-(7426)-96-15-0
FDA Registration: 9611456 Year Established: 1953 Quality: ISO 9001, ISO 13485 Certified
Products: Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Skin hooks, Surgical Trays (FDA Code: LRP), ...
Allgaier Instrumente Gmbh manufactures medical instruments. Our products are used in the dental, cardiovascular, osteosynthesis and endoscopy fields. We offer light sources, cameras, optics, trocars, more...
www.allgaier-instrumente.de | Send Inquiry | Phone: +49-(7426)-96-15-0
FDA Registration: 9611456 Year Established: 1953 Quality: ISO 9001, ISO 13485 Certified
Products: Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Skin hooks, Surgical Trays (FDA Code: LRP), ...
Allgaier Instrumente Gmbh manufactures medical instruments. Our products are used in the dental, cardiovascular, osteosynthesis and endoscopy fields. We offer light sources, cameras, optics, trocars, more...
Waldemar Link GmbH & Co. KG | Address: Barkhausenweg 10, Hamburg D-22339, Germany
www.waldemarlink.com | Send Inquiry | Phone: +49-(40)-539950
FDA Registration: 3004371426
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Electrode Cables (FDA Code: IKD), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), ...
Waldemar Link GmbH & Co. KG specializes in supplying hospital products. We also manufacture orthopedic implants and surgical instruments. Our implants are manufactured under high-tech conditions. Our more...
www.waldemarlink.com | Send Inquiry | Phone: +49-(40)-539950
FDA Registration: 3004371426
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Electrode Cables (FDA Code: IKD), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), ...
Waldemar Link GmbH & Co. KG specializes in supplying hospital products. We also manufacture orthopedic implants and surgical instruments. Our implants are manufactured under high-tech conditions. Our more...
SMT Schilling Metalltechnik GmbH | Address: Griesweg 33, MA¼hlheim 78570, Germany
www.smt-metalltechnik.de | Send Inquiry | Phone: +49-(07463)-99309.0
FDA Registration: 9680619
Products: Forceps (FDA Code: HTD), Surgical Wire (FDA Code: LRN), Non-Powered Surgical Instrument (FDA Code: HAO), Bending/Contouring Instrument (FDA Code: HXP), Calipers (FDA Code: KTZ), Orthopedic Cutting Instrument (FDA Code: HTZ), ...
SMT Schilling Metalltechnik GmbH is a manufacturer of surgical instruments and apparatus. We offer instruments such as pliers, scissors, cutters, screwdrivers, forceps and calipers. more...
www.smt-metalltechnik.de | Send Inquiry | Phone: +49-(07463)-99309.0
FDA Registration: 9680619
Products: Forceps (FDA Code: HTD), Surgical Wire (FDA Code: LRN), Non-Powered Surgical Instrument (FDA Code: HAO), Bending/Contouring Instrument (FDA Code: HXP), Calipers (FDA Code: KTZ), Orthopedic Cutting Instrument (FDA Code: HTZ), ...
SMT Schilling Metalltechnik GmbH is a manufacturer of surgical instruments and apparatus. We offer instruments such as pliers, scissors, cutters, screwdrivers, forceps and calipers. more...
Mondeal Medical Systems Gmbh | Address: Gewerbering 7, Muhlheim A.D. Donau 78750, Germany
www.mondeal.de | Send Inquiry | Phone: +49-(7463)-99307-0
FDA Registration: 3004517085
Products: Surgical Trays (FDA Code: LRP), Cannulated Screw Fracture Fixation System, Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Self-Drilling Screws, ...
Mondeal Medical Systems Gmbh deals with medical systems. We offer oral & cranio-maxillofacial systems and traumas. Oral and cranial-maxillofacial system components are used for oral, maxillofacial, an more...
www.mondeal.de | Send Inquiry | Phone: +49-(7463)-99307-0
FDA Registration: 3004517085
Products: Surgical Trays (FDA Code: LRP), Cannulated Screw Fracture Fixation System, Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Self-Drilling Screws, ...
Mondeal Medical Systems Gmbh deals with medical systems. We offer oral & cranio-maxillofacial systems and traumas. Oral and cranial-maxillofacial system components are used for oral, maxillofacial, an more...
G. Hipp & Sohn | Address: Carl-Benz-Str. 1, Neuhausen 78579, Germany
Phone: +49-(7467)-1463
FDA Registration: 8010252
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), ...
G. Hipp & Sohn deals with elevator, hemostat, needle holders, pliers, forceps and orthopedic products. We also offer orthodontic products, collar & crown, retractors, cutters and twisters. more...
Phone: +49-(7467)-1463
FDA Registration: 8010252
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), ...
G. Hipp & Sohn deals with elevator, hemostat, needle holders, pliers, forceps and orthopedic products. We also offer orthodontic products, collar & crown, retractors, cutters and twisters. more...
S.U.A. Martin GmbH & Co. KG | Address: Uhlandstr. 17, Rietheim-Weilheim 78604, Germany
Phone: +49-(7461)-73824
FDA Registration: 8010386
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
S.U.A. Martin GmbH & Co. KG offers needle holders. more...
Phone: +49-(7461)-73824
FDA Registration: 8010386
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
S.U.A. Martin GmbH & Co. KG offers needle holders. more...
Stryker Trauma Gmbh | Address: Prof.-Kuentscher-Strasse 1-5, Schoenkirchen D-24232, Germany
Phone: +49-(4348)-702-0
FDA Registration: 9610622 Year Established: 1941
Products: Forceps (FDA Code: HTD), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Wire Twisters (FDA Code: HXS), Bone Cement (FDA Code: LOD), Blood pressure Cuffs (FDA Code: DXQ), ...
Stryker Trauma GmbH offers orthopedic manual surgical instruments, pneumatic orthopedic power tool systems, screws and staples. more...
Phone: +49-(4348)-702-0
FDA Registration: 9610622 Year Established: 1941
Products: Forceps (FDA Code: HTD), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Wire Twisters (FDA Code: HXS), Bone Cement (FDA Code: LOD), Blood pressure Cuffs (FDA Code: DXQ), ...
Stryker Trauma GmbH offers orthopedic manual surgical instruments, pneumatic orthopedic power tool systems, screws and staples. more...
Seifring - Instrumente GmbH | Address: Gunninger Str. 35, Seitingen-Oberflacht 78606, Germany
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Biopsy Punches (FDA Code: FCI), ...
Seifring - Instrumente GmbH specializes in offering hemostatic clips. Our products include self-retaining retractors, vaginal dilators, bone cutting forceps, surgical hammer, bone holding forceps, abd more...
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Biopsy Punches (FDA Code: FCI), ...
Seifring - Instrumente GmbH specializes in offering hemostatic clips. Our products include self-retaining retractors, vaginal dilators, bone cutting forceps, surgical hammer, bone holding forceps, abd more...
Otto Ruettgers Gmbh & Co. KG | Address: Roonstr. 17-19, Solingen 42699, Germany
www.otto-ruettgers.com | Phone: +49-(212)-330-983
FDA Registration: 8010329 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Scalpel Handle (FDA Code: GDZ), Nail Extractors (FDA Code: HWB), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Spare Hook for K Nail Extractor, Square Nail Extractor Hook, ...
Otto Ruettgers Gmbh & Co. KG offers various types of orthopedic extractors, orthopedic instruments, scalpel blades & handles and scissors. more...
www.otto-ruettgers.com | Phone: +49-(212)-330-983
FDA Registration: 8010329 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002, CE Certified
Products: Scalpel Handle (FDA Code: GDZ), Nail Extractors (FDA Code: HWB), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Spare Hook for K Nail Extractor, Square Nail Extractor Hook, ...
Otto Ruettgers Gmbh & Co. KG offers various types of orthopedic extractors, orthopedic instruments, scalpel blades & handles and scissors. more...
Gustav Weck | Address: Lohdorfer Str. 187a, Solingen D-42699, Germany
www.gustav-weck-solingen.de | Send Inquiry | Phone: +49-(212)-62219
Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Umbilical Artery Catheter (FDA Code: FOS), Vascular Clamps (FDA Code: DXC), Forceps Needle Holders, Stainless Steel Needle Holders, ...
Gustav Weck is a manufacturer of surgical instruments. more...
www.gustav-weck-solingen.de | Send Inquiry | Phone: +49-(212)-62219
Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Umbilical Artery Catheter (FDA Code: FOS), Vascular Clamps (FDA Code: DXC), Forceps Needle Holders, Stainless Steel Needle Holders, ...
Gustav Weck is a manufacturer of surgical instruments. more...
Friedrich Daniels Gmbh | Address: Donhoffstr. 6, Solingen 42655, Germany
www.friedrich-daniels.com | Send Inquiry | Phone: +49-(212)-810050
FDA Registration: 9611390
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Umbilical Artery Catheter (FDA Code: FOS), Vascular Clamps (FDA Code: DXC), Forceps Needle Holders, Stainless Steel Needle Holders, ...
Friedrich Daniels Gmbh specializes in surgical instruments. Our surgical instruments include bone probes, modular spine distractor, bone cutting instruments, elevators, soft grip rongeurs, punches, so more...
www.friedrich-daniels.com | Send Inquiry | Phone: +49-(212)-810050
FDA Registration: 9611390
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Umbilical Artery Catheter (FDA Code: FOS), Vascular Clamps (FDA Code: DXC), Forceps Needle Holders, Stainless Steel Needle Holders, ...
Friedrich Daniels Gmbh specializes in surgical instruments. Our surgical instruments include bone probes, modular spine distractor, bone cutting instruments, elevators, soft grip rongeurs, punches, so more...
Hammacher Instrumente Gmbh | Address: Steinendorfer Str. 27, Solingen 42699, Germany
www.hammacher.de | Send Inquiry | Phone: +49-(212)-262500
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Double Prong Skin Hooks, Single Prong Skin Hooks, ...
Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical more...
www.hammacher.de | Send Inquiry | Phone: +49-(212)-262500
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Double Prong Skin Hooks, Single Prong Skin Hooks, ...
Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical more...
Robert Mueller Instrumente | Address: Max-Planck-Str. 5/2c, Spaichingen D-7208, Germany
Phone: 074-245-674
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Lateral Vaginal Retractor, Rib Rongeurs (FDA Code: HTX), Orthopedic Cutting Instrument (FDA Code: HTZ), Catheter Punch Instrument (FDA Code: FEX), ...
Robert Mueller Instrumente offers vaginal retractors and various types of forceps, punches & rongeurs. more...
Phone: 074-245-674
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Lateral Vaginal Retractor, Rib Rongeurs (FDA Code: HTX), Orthopedic Cutting Instrument (FDA Code: HTZ), Catheter Punch Instrument (FDA Code: FEX), ...
Robert Mueller Instrumente offers vaginal retractors and various types of forceps, punches & rongeurs. more...
Max Hauser Suddeutsche Chirurgie Mechanik Gmbh | Address: Kettelerstrasse 44-46, Tuttlingen D-78532, Germany
www.sueddeutsche-chirurgie.de | Send Inquiry | Phone: +49-(7461)-71089
FDA Registration: 8010422 Quality: EN ISO 13485 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Retractor (FDA Code: GAD), ...
Max Hauser Suddeutsche Chirurgie Mechanik Gmbh offers retractors and spreader systems for heart surgery and neurosurgery. We also manufacture heart and vessel clamps & forceps. We use materials such a more...
www.sueddeutsche-chirurgie.de | Send Inquiry | Phone: +49-(7461)-71089
FDA Registration: 8010422 Quality: EN ISO 13485 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Retractor (FDA Code: GAD), ...
Max Hauser Suddeutsche Chirurgie Mechanik Gmbh offers retractors and spreader systems for heart surgery and neurosurgery. We also manufacture heart and vessel clamps & forceps. We use materials such a more...
Dufner Instrumente GmbH | Address: Föhrenstraße 9, Tuttlingen 78532, Germany
www.dufner-tuttlingen.de | Send Inquiry | Phone: +49-(7461)-3697
FDA Registration: 9612278
Products: Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
Dufner Instrumente GmbH is a manufacturer of surgical instruments. We manufacture various laparoscopy products including grasping forceps, scissors, biopsy forceps, needle holders, endoscopes, light g more...
www.dufner-tuttlingen.de | Send Inquiry | Phone: +49-(7461)-3697
FDA Registration: 9612278
Products: Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), ...
Dufner Instrumente GmbH is a manufacturer of surgical instruments. We manufacture various laparoscopy products including grasping forceps, scissors, biopsy forceps, needle holders, endoscopes, light g more...
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FDA Code / Regulation: HTZ / 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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