Tamps Suppliers
Limit companies to: Worldwide USA
VG Innovations, Inc | Address: 1399 Ashleybrook Lane, Suite 110, Winston Salem, North Carolina 27103, USA 
www.vginnovations.com | Send Inquiry | Phone: +1-(336)-7602012
FDA Registration: 3006982954
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Medical Devices, Treatment for Back Pain, Surgical Caps (FDA Code: FYF), Ophthalmic Cannula (FDA Code: HMX), ...
VG Innovations, Inc is a medical device company focusing on the development of a broad range of advanced, high-performance and minimally invasive spinal implants. VerteLoc™ is a minimally invasi more...
www.vginnovations.com | Send Inquiry | Phone: +1-(336)-7602012
FDA Registration: 3006982954
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Medical Devices, Treatment for Back Pain, Surgical Caps (FDA Code: FYF), Ophthalmic Cannula (FDA Code: HMX), ...
VG Innovations, Inc is a medical device company focusing on the development of a broad range of advanced, high-performance and minimally invasive spinal implants. VerteLoc™ is a minimally invasi more...
Ortho-Med, Inc. | Address: 3208 S.E. 13th Ave., Portland, Oregon 97202, USA
www.orthomedinc.com | Send Inquiry | Phone: +1-(503)-234-9691, 800-547-5571
FDA Registration: 3019455 Year Established: 1970 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Mallets, Chisels, Osteotomes, Suture Passers, Biopsy Punches (FDA Code: FCI), General Surgical Instruments, ...
Ortho-Med, Inc. specializes in surgical instruments. Our product list comprises of wire & pin implants, spinal rongeurs & punches, bone curettes, osteotomes, chisels and bone files. Our hot or cold ve more...
www.orthomedinc.com | Send Inquiry | Phone: +1-(503)-234-9691, 800-547-5571
FDA Registration: 3019455 Year Established: 1970 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Mallets, Chisels, Osteotomes, Suture Passers, Biopsy Punches (FDA Code: FCI), General Surgical Instruments, ...
Ortho-Med, Inc. specializes in surgical instruments. Our product list comprises of wire & pin implants, spinal rongeurs & punches, bone curettes, osteotomes, chisels and bone files. Our hot or cold ve 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Arthroscopes (FDA Code: HRX), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), ...
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...
Spine Smith L.P. | Address: 93 Red River, Austin, Texas 78701, USA
Send Inquiry | Phone: +1-(512)-206-0770
FDA Registration: 3006404071
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Tamps (FDA Code: HXG), Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), ...
Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biolog more...
Send Inquiry | Phone: +1-(512)-206-0770
FDA Registration: 3006404071
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Tamps (FDA Code: HXG), Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), ...
Spine Smith L.P. designs, develops and markets implants & biologics for surgical fixation, correction & tissue regeneration of the spine. Our product area includes medical devices, regenerative biolog more...
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...
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...
Central Medical Technologies, Incorporated | Address: 3f, No.298, Ruei-Guang Road, Neihu District, Taipei 11491, Taiwan 
Phone: +886-(2)-26584807
Products: Tamps (FDA Code: HXG), Calcium Compound Bone Void Filler (FDA Code: MQV), Cement Dispenser (FDA Code: KIH), Arthroscopic Accessories (FDA Code: NBH), ...
Central Medical Technologies, Incorporated specializes in spinal surgery products and implants. We also deal with calcium compound bone void filler. more...
Phone: +886-(2)-26584807
Products: Tamps (FDA Code: HXG), Calcium Compound Bone Void Filler (FDA Code: MQV), Cement Dispenser (FDA Code: KIH), Arthroscopic Accessories (FDA Code: NBH), ...
Central Medical Technologies, Incorporated specializes in spinal surgery products and implants. We also deal with calcium compound bone void filler. 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...
A.N.A Amity Impex | Address: A.N.A Square, Airport Road, Muradpur, Sialkot 51310, Pakistan
www.anaamity.com | Send Inquiry | Phone: +92-(52)-4268654
Quality: ISO-9001 Certified
Products: Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Scalpels, ...
A.N.A Amity Impex is a manufacturer and exporter of surgical, dental, veterinary, manicure & pedicure implements. We are an ISO 9001:2000, pGMP and CE certified company. Our surgical instruments inclu more...
www.anaamity.com | Send Inquiry | Phone: +92-(52)-4268654
Quality: ISO-9001 Certified
Products: Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Scalpels, ...
A.N.A Amity Impex is a manufacturer and exporter of surgical, dental, veterinary, manicure & pedicure implements. We are an ISO 9001:2000, pGMP and CE certified company. Our surgical instruments inclu more...
Sintea Biotech Spa | Address: Via Aquileia 33/h, Baranzate 20021, Italy
Phone: +39-(2)-38204222
FDA Registration: 3003475199
Products: Arthroscopes (FDA Code: HRX), Tamps (FDA Code: HXG), Invasive Traction Component (FDA Code: JEC), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), ...
Sintea Biotech Spa deals with anterior cervical plating systems, screws, traction components and trauma fixation systems. more...
Phone: +39-(2)-38204222
FDA Registration: 3003475199
Products: Arthroscopes (FDA Code: HRX), Tamps (FDA Code: HXG), Invasive Traction Component (FDA Code: JEC), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), ...
Sintea Biotech Spa deals with anterior cervical plating systems, screws, traction components and trauma fixation systems. more...
3by Ltd. | Address: P.O.B. 65 Industrial Park Tefen, Tefen 24959, Israel
www.3by.com | Send Inquiry | Phone: +972-(4)-9872332
FDA Registration: 3004201393 Quality: ISO 9001:2000 Certified
Products: Product Design & Development, Needles, Arthroscopes (FDA Code: HRX), Embolectomy Catheters (FDA Code: DXE), Packaging, Quality Assurance & Control, ...
3by Ltd. specializes in turn-key projects of medical components, devices and systems. We provide clean room production, sophisticated plastic injection molding services, technical design assistance, a more...
www.3by.com | Send Inquiry | Phone: +972-(4)-9872332
FDA Registration: 3004201393 Quality: ISO 9001:2000 Certified
Products: Product Design & Development, Needles, Arthroscopes (FDA Code: HRX), Embolectomy Catheters (FDA Code: DXE), Packaging, Quality Assurance & Control, ...
3by Ltd. specializes in turn-key projects of medical components, devices and systems. We provide clean room production, sophisticated plastic injection molding services, technical design assistance, a 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...
Moeller Medical Gmbh | Address: Wasserkuppenstrabe 29-31, Fulda 36043, Germany
www.moeller-medical.com | Send Inquiry | Phone: +49-(661)-941-950
FDA Registration: 3006611221
Products: CSF Drainage System, Drill Bit (FDA Code: HTW), Disposable Liposuction Cannula, Infiltration Pump, Digital Preset Monitor, Tamps (FDA Code: HXG), Instrument for Spine Surgery, ...
Moeller Medical Gmbh deals with neurosurgical spine, aesthetic medicine and blood transfusion segments. Our neurosurgical product Liquoguard ® is a constant monitor of the normal CSF pressure puls more...
www.moeller-medical.com | Send Inquiry | Phone: +49-(661)-941-950
FDA Registration: 3006611221
Products: CSF Drainage System, Drill Bit (FDA Code: HTW), Disposable Liposuction Cannula, Infiltration Pump, Digital Preset Monitor, Tamps (FDA Code: HXG), Instrument for Spine Surgery, ...
Moeller Medical Gmbh deals with neurosurgical spine, aesthetic medicine and blood transfusion segments. Our neurosurgical product Liquoguard ® is a constant monitor of the normal CSF pressure puls 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...
Otto Leibinger L-Dent GmbH | Address: 27 Griesweg, Muehlheim 78570, Germany
www.otto-leibinger.de | Send Inquiry | Phone: +49-(7463)-7232
FDA Registration: 9614986
Products: Surgical Retractor Systems (FDA Code: GAD), Bone Taps (FDA Code: HWX), Tamps (FDA Code: HXG), Bone Mill (FDA Code: LYS), General use Surgical Curettes (FDA Code: FZS), Surgical Retractor (FDA Code: GAD), ...
Otto Leibinger L-Dent GmbH is a manufacturer of dental hand instruments. Our extensive array of products ranges from dental hand instruments such as instruments for fillings and periodontal treatment, more...
www.otto-leibinger.de | Send Inquiry | Phone: +49-(7463)-7232
FDA Registration: 9614986
Products: Surgical Retractor Systems (FDA Code: GAD), Bone Taps (FDA Code: HWX), Tamps (FDA Code: HXG), Bone Mill (FDA Code: LYS), General use Surgical Curettes (FDA Code: FZS), Surgical Retractor (FDA Code: GAD), ...
Otto Leibinger L-Dent GmbH is a manufacturer of dental hand instruments. Our extensive array of products ranges from dental hand instruments such as instruments for fillings and periodontal treatment, more...
Tutogen Medical Gmbh | Address: Industriestrasse 6, Neunkirchen a Brand 91077, Germany
www.tutogen.de | Send Inquiry | Phone: +49-(9134)-99 88 - 5 00
FDA Registration: 3002924436 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Bone Rasps (FDA Code: HTR), Non-Absorbable Sutures (FDA Code: GAO), Surgical Mesh (FDA Code: FTM), Non-Implanted Hemodialysis Catheters (FDA Code: MPB), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Tutogen Medical Gmbh develops pharmaceutical and medical devices. Our allogeneic bone grafts and xenogeneic origin of orthopedic & trauma products are used successfully worldwide. Our tissue sparing T more...
www.tutogen.de | Send Inquiry | Phone: +49-(9134)-99 88 - 5 00
FDA Registration: 3002924436 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Bone Rasps (FDA Code: HTR), Non-Absorbable Sutures (FDA Code: GAO), Surgical Mesh (FDA Code: FTM), Non-Implanted Hemodialysis Catheters (FDA Code: MPB), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Tutogen Medical Gmbh develops pharmaceutical and medical devices. Our allogeneic bone grafts and xenogeneic origin of orthopedic & trauma products are used successfully worldwide. Our tissue sparing T more...
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FDA Code / Regulation: HXG / 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.
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