Nail Extractors Suppliers
Limit companies to: Worldwide USA
K2M, Inc. | Address: 751 Miller Dr. S.E., Suite F-1, Leesburg, Virginia 20175, USA 
www.k2m.com | Send Inquiry | Phone: +1-(866)-526-4171
FDA Registration: 3004774118
Products: Probes (FDA Code: HXB), Hook, Screw and Rod Systems, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
K2M, Inc. specializes in products related to spinal disorders. Our product portfolio includes Mesa® spinal systems, Range® spinal systems, Denali® spinal systems, Serengeti® minimally more...
www.k2m.com | Send Inquiry | Phone: +1-(866)-526-4171
FDA Registration: 3004774118
Products: Probes (FDA Code: HXB), Hook, Screw and Rod Systems, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), ...
K2M, Inc. specializes in products related to spinal disorders. Our product portfolio includes Mesa® spinal systems, Range® spinal systems, Denali® spinal systems, Serengeti® minimally more...
Surgical Implant Generation Network (sign) | Address: 451 Hills Street, Richland, Washington 99354, USA
www.sign-post.org | Send Inquiry | Phone: +1-(509)-371-1107.
FDA Registration: 3034525
Products: Probes (FDA Code: HXB), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Nail Extractors (FDA Code: HWB), Bone Clamp (FDA Code: HXD), ...
Surgical Implant Generation Network (sign) is a manufacturer of intramedullary nailing systems. Our intramedullary(IM) nailing systems are designed to repair a broader range of fractures. Our hip cons more...
www.sign-post.org | Send Inquiry | Phone: +1-(509)-371-1107.
FDA Registration: 3034525
Products: Probes (FDA Code: HXB), Drill Bit (FDA Code: HTW), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Nail Extractors (FDA Code: HWB), Bone Clamp (FDA Code: HXD), ...
Surgical Implant Generation Network (sign) is a manufacturer of intramedullary nailing systems. Our intramedullary(IM) nailing systems are designed to repair a broader range of fractures. Our hip cons more...
Bradshaw Medical, Inc. | Address: 5732-95th Ave., Suite 100, Kenosha, Wisconsin 53144, USA
www.bradshaw-medical.com | Send Inquiry | Phone: +1-(262)-925-1374
FDA Registration: 3006846753
Products: Probes (FDA Code: HXB), Bone Awls and Probes, Wire Twisters (FDA Code: HXS), Periosteal Elevator, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), ...
Bradshaw Medical, Inc specializes in the production of orthopedic and spinal surgical instruments. Our products include spinal instruments, bone awls, probes and sounders. Our spinal instruments are S more...
www.bradshaw-medical.com | Send Inquiry | Phone: +1-(262)-925-1374
FDA Registration: 3006846753
Products: Probes (FDA Code: HXB), Bone Awls and Probes, Wire Twisters (FDA Code: HXS), Periosteal Elevator, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), ...
Bradshaw Medical, Inc specializes in the production of orthopedic and spinal surgical instruments. Our products include spinal instruments, bone awls, probes and sounders. Our spinal instruments are S more...
Sandmar Surgical Instruments, Inc. | Address: 9031 58th Place, Kenosha, Wisconsin 53406, USA
Phone: +1-(262)-925-8342
Products: Probes (FDA Code: HXB), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), ...
Sandmar Surgical Instruments, Inc. deals with ratcheting screwdrivers, torque drivers, silicon fixed handles and adaptors. We also focus on rod & plate benders, bone probes, awls, box chisels, pedicle more...
Phone: +1-(262)-925-8342
Products: Probes (FDA Code: HXB), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), ...
Sandmar Surgical Instruments, Inc. deals with ratcheting screwdrivers, torque drivers, silicon fixed handles and adaptors. We also focus on rod & plate benders, bone probes, awls, box chisels, pedicle more...
Parcus Medical , L.L.C. | Address: 839 South Neenah Avenue, Sevastopol, Wisconsin 54235, USA
Phone: +1-(877)-7462972
FDA Registration: 3007319107
Products: Bone Taps (FDA Code: HWX), Nail Extractors (FDA Code: HWB), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Bone Fixation Screw (FDA Code: HWC), Ligament Drill Guide (FDA Code: LXI), Non-Invasive Traction Component (FDA Code: KQZ), ...
Parcus Medical, L.L.C. deals with surgical solutions. Our products include bone fixation screws, bone taps, nail extractors and orthopedic wire passers. We also offer screwdrivers and soft tissue non- more...
Phone: +1-(877)-7462972
FDA Registration: 3007319107
Products: Bone Taps (FDA Code: HWX), Nail Extractors (FDA Code: HWB), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Bone Fixation Screw (FDA Code: HWC), Ligament Drill Guide (FDA Code: LXI), Non-Invasive Traction Component (FDA Code: KQZ), ...
Parcus Medical, L.L.C. deals with surgical solutions. Our products include bone fixation screws, bone taps, nail extractors and orthopedic wire passers. We also offer screwdrivers and soft tissue non- more...
Xiros Plc | Address: 28-30 Blenheim Terrace, Leeds, United Kingdom 
Phone: 011-324-4694
FDA Registration: 8044102
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), Powered Exerciser (FDA Code: BXB), Biological Vascular Graft, Disposable Suture Needle (FDA Code: GAB), Instrument Surgical Guide (FDA Code: FZX), ...
Xiros Plc are providers of continuous passive motion machines, graft harvesting instrument sets and cradle fixation devices. more...
Phone: 011-324-4694
FDA Registration: 8044102
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), Powered Exerciser (FDA Code: BXB), Biological Vascular Graft, Disposable Suture Needle (FDA Code: GAB), Instrument Surgical Guide (FDA Code: FZX), ...
Xiros Plc are providers of continuous passive motion machines, graft harvesting instrument sets and cradle fixation devices. more...
Howmedica International Ltd | Address: 622 Western Avenue, Park Royal, London W3 0TF, United Kingdom
Phone: +44-(181)-992-8044
Employee Count: ~150 Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Bone Drills, Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Arthroscopy Drill Guides, ...
Howmedica International Ltd specializes in offering orthopedic products. Our products include bone fixation plate, bone drills, femoral prosthetic implants, foot prosthesis, human bone rasps, nail ext more...
Phone: +44-(181)-992-8044
Employee Count: ~150 Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Bone Drills, Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Arthroscopy Drill Guides, ...
Howmedica International Ltd specializes in offering orthopedic products. Our products include bone fixation plate, bone drills, femoral prosthetic implants, foot prosthesis, human bone rasps, nail ext more...
JMF (T) Group Co., Ltd. | Address: 75/74 Moo 11, Paholyothin Rd., Klongnueng, Klongluang, Pathunthanee, TH-13 12120, Thailand
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Resectoscopes (FDA Code: FJL), Surgical Trays (FDA Code: LRP), ...
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: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Resectoscopes (FDA Code: FJL), Surgical Trays (FDA Code: LRP), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), ...
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...
Zimmer Gmbh | Address: Sulzer Allee 8, Winterthur CH-8404, Switzerland
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
FDA Registration: 9613350
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Zimmer Gmbh designs and manufactures reconstructive spinal and dental implants, trauma and related orthopedic surgical products. We also offer joint replacement solutions for knee pain and hip pain, a more...
B.T.I. Biotechnology Institute, S.L. | Address: San Antonio, 15, 5th, Vitoria (Alava) 01005, Spain
www.bti-implant.es | Send Inquiry | Phone: +34-(945)-140024
FDA Registration: 3004417597
Products: Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), Nail Extractors (FDA Code: HWB), Refrigerated Centrifuges (FDA Code: JQC), Scalpel Blade (FDA Code: GES), Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
B.T.I. Biotechnology Institute, S.L. is a designer and manufacturer of dental implants, prosthetic components & surgical instruments. Our products include surgical wrenches, surgical kits, surgical co more...
www.bti-implant.es | Send Inquiry | Phone: +34-(945)-140024
FDA Registration: 3004417597
Products: Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), Nail Extractors (FDA Code: HWB), Refrigerated Centrifuges (FDA Code: JQC), Scalpel Blade (FDA Code: GES), Labeled Medical Laboratory Equipment (FDA Code: LXG), ...
B.T.I. Biotechnology Institute, S.L. is a designer and manufacturer of dental implants, prosthetic components & surgical instruments. Our products include surgical wrenches, surgical kits, surgical co more...
Saleem Surgio (regd) | Address: Karimpura Rd, Sialkot 22161, Pakistan
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Obstetrical Forceps (FDA Code: HDA), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Saleem Surgio (regd) provides surgical instruments for use in general surgery, obstetrics and gynecology, orthopedics, ophthalmology, and ENT surgery. more...
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Obstetrical Forceps (FDA Code: HDA), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, ...
Saleem Surgio (regd) provides surgical instruments for use in general surgery, obstetrics and gynecology, orthopedics, ophthalmology, and ENT surgery. more...
Hilbro Private Limited | Address: P.O. Box 22, Sialkot, Pakistan
www.hilbrointl.com | Send Inquiry | Phone: +92-(52)-6526276-78
FDA Registration: 8040884 Year Established: 1961 Annual Revenues: USD 1-5 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Cardiology Surgery Instruments, Elevators, Forceps (FDA Code: HTD), Mallets, Retractors, ...
Hilbro Private Limited manufactures surgical and dental instruments. We are ISO 9002 and ISO 13485 certified, FDA registered & CE marked. Our product categories are diagnostics, scalpels, scissors, bo more...
www.hilbrointl.com | Send Inquiry | Phone: +92-(52)-6526276-78
FDA Registration: 8040884 Year Established: 1961 Annual Revenues: USD 1-5 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Cardiology Surgery Instruments, Elevators, Forceps (FDA Code: HTD), Mallets, Retractors, ...
Hilbro Private Limited manufactures surgical and dental instruments. We are ISO 9002 and ISO 13485 certified, FDA registered & CE marked. Our product categories are diagnostics, scalpels, scissors, bo more...
Falcon Surgical Co (Pvt) Ltd. | Address: Wazirabad Rd., P.O. Box 134, Near Village Golophala Ugoki, Sialkot, Punjab, Pakistan
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
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), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
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), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
Tae Yeon Medical Co Ltd | Address: #1642-4 Donghwa-Ri, Munmak-eup, wonju-Si Gangwon-do 220-801, Korea, Republic Of 
www.tymedical.com | Phone: +82-(32)-235-7375
Products: Probes (FDA Code: HXB), Bone Taps (FDA Code: HWX), Nail Extractors (FDA Code: HWB), Wire Cutters (FDA Code: HXZ), Laser Power Probe, Laparoscopic Probes, ...
Tae Yeon Medical Co Ltd manufactures spinal systems, external fixator systems, internal fixator systems, trauma systems and surgical instruments. Our external fixation system is used for distal radius more...
www.tymedical.com | Phone: +82-(32)-235-7375
Products: Probes (FDA Code: HXB), Bone Taps (FDA Code: HWX), Nail Extractors (FDA Code: HWB), Wire Cutters (FDA Code: HXZ), Laser Power Probe, Laparoscopic Probes, ...
Tae Yeon Medical Co Ltd manufactures spinal systems, external fixator systems, internal fixator systems, trauma systems and surgical instruments. Our external fixation system is used for distal radius more...
Gpc Medical Limited | Address: G-3, Vikas Puri, New Delhi, Delhi 110018, India 
www.gpc-medical.com | Send Inquiry | Phone: ++91-(11)-45545151
FDA Registration: 3006513362
Products: Medical Thermometers, Probes (FDA Code: HXB), Face Masks, Incubators, Digital Microscopes, Wire Twisters (FDA Code: HXS), ...
Gpc Medical Limited deals with hospital equipment, devices and instruments. Our products include orthopedic implants, rehabilitation aids, stainless steel hospital hollow wares and sterilizers. We off more...
www.gpc-medical.com | Send Inquiry | Phone: ++91-(11)-45545151
FDA Registration: 3006513362
Products: Medical Thermometers, Probes (FDA Code: HXB), Face Masks, Incubators, Digital Microscopes, Wire Twisters (FDA Code: HXS), ...
Gpc Medical Limited deals with hospital equipment, devices and instruments. Our products include orthopedic implants, rehabilitation aids, stainless steel hospital hollow wares and sterilizers. We off more...
Narang Medical Limited | Address: Narang Tower, 46 Community Centre, Naraina Ph-I, New Delhi, Delhi 110028, India
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Medical Thermometers, Stethoscopes, Umbilical Cord Clamps, Vacuum Extractors, Autoclaves, Dry Heat Sterilizers (FDA Code: KMH), ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Medical Thermometers, Stethoscopes, Umbilical Cord Clamps, Vacuum Extractors, Autoclaves, Dry Heat Sterilizers (FDA Code: KMH), ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Stork Instrumente Gmbh | Address: Engenerstr. 29, Emmingen-Liptingen 78576, Germany 
Phone: +49-(7465)-825
FDA Registration: 8010547
Products: Bone Hooks (FDA Code: KIK), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), Ligature Carrier Set (FDA Code: GEJ), Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), ...
Stork Instrumente Gmbh provides surgical retractor systems, ligature carrier set, orthopedic wire passer, measuring rulers & caliper products. We also offer mobilizer, manual osteotome, nail extractor more...
Phone: +49-(7465)-825
FDA Registration: 8010547
Products: Bone Hooks (FDA Code: KIK), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), Ligature Carrier Set (FDA Code: GEJ), Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), ...
Stork Instrumente Gmbh provides surgical retractor systems, ligature carrier set, orthopedic wire passer, measuring rulers & caliper products. We also offer mobilizer, manual osteotome, nail extractor more...
Mahe-Barthelmes Medizintechnik Gmbh | Address: Friedrich Wohler Str 10, Emmingen-Liptingen 78576, Germany
www.mahemedical.net | Send Inquiry | Phone: +49-(7465)-9275-0
FDA Registration: 8010447 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Resectoscopes (FDA Code: FJL), Surgical Trays (FDA Code: LRP), ...
Mahe-Barthelmes Medizintechnik Gmbh provides medical equipment. We offer products for endoscopy, arthroscopy, ENT, laparoscopy and urology. The endoscopy products are insufflator 1400, purgorator 5100 more...
www.mahemedical.net | Send Inquiry | Phone: +49-(7465)-9275-0
FDA Registration: 8010447 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Hooks (FDA Code: KIK), Resectoscopes (FDA Code: FJL), Surgical Trays (FDA Code: LRP), ...
Mahe-Barthelmes Medizintechnik Gmbh provides medical equipment. We offer products for endoscopy, arthroscopy, ENT, laparoscopy and urology. The endoscopy products are insufflator 1400, purgorator 5100 more...
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FDA Code / Regulation: HWB / 888.4540
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
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 888.9.
