Wrench Suppliers
Limit companies to: Worldwide USA
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: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
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: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
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...
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: Hook, Screw and Rod Systems, Anterior Lumbar Plate System, Polyaxial Pedicular Screw System, Pedicle Screw System, Vertebral Body Replacement System, Cervical Plate System, ...
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: Hook, Screw and Rod Systems, Anterior Lumbar Plate System, Polyaxial Pedicular Screw System, Pedicle Screw System, Vertebral Body Replacement System, Cervical Plate System, ...
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...
Evergreen Orthopedic Research Lab | Address: 11321 NE 120th Street, K-405, Bldg W, Kirkland, Washington 98034-4399, USA
www.eorl.org | Send Inquiry | Phone: +1-(425)-284-7262
FDA Registration: 3007190523 Quality: ISO 9000 Certified
Products: Orthopedic Surgical Instruments, Minimally Invasive Hip Instruments, Drill Bit (FDA Code: HTW), Cadaver Dissection Table, Orthopedic Manual Surgical Instrument (FDA Code: LXH), Screwdriver (FDA Code: HXX), Wrench (FDA Code: HXC), ...
Evergreen Orthopedic Research Lab focuses on surgical technologies to improve patient care. We provide computer navigation, minimally invasive surgical techniques and instruments that offer improvemen more...
www.eorl.org | Send Inquiry | Phone: +1-(425)-284-7262
FDA Registration: 3007190523 Quality: ISO 9000 Certified
Products: Orthopedic Surgical Instruments, Minimally Invasive Hip Instruments, Drill Bit (FDA Code: HTW), Cadaver Dissection Table, Orthopedic Manual Surgical Instrument (FDA Code: LXH), Screwdriver (FDA Code: HXX), Wrench (FDA Code: HXC), ...
Evergreen Orthopedic Research Lab focuses on surgical technologies to improve patient care. We provide computer navigation, minimally invasive surgical techniques and instruments that offer improvemen more...
Sandmar Surgical Instruments, Inc. | Address: 9031 58th Place, Kenosha, Wisconsin 53406, USA
Phone: +1-(262)-925-8342
Products: Bone Taps (FDA Code: HWX), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Bending/Contouring Instrument (FDA Code: HXP), Broach (FDA Code: HTQ), ...
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: Bone Taps (FDA Code: HWX), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Bending/Contouring Instrument (FDA Code: HXP), Broach (FDA Code: HTQ), ...
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...
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: Screwdrivers & Torques, Ratcheting Screwdriver, Spinal Instrument, Rod Bender, Spinal Instrument, Rod Pusher, Screwdriver (FDA Code: HXX), Spinal Distractors, ...
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: Screwdrivers & Torques, Ratcheting Screwdriver, Spinal Instrument, Rod Bender, Spinal Instrument, Rod Pusher, Screwdriver (FDA Code: HXX), Spinal Distractors, ...
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...
Feiter's Inc. | Address: 8700 West Port Ave., Milwaukee, Wisconsin 53224, USA
Phone: +1-(414)-355-7575
Products: Wheelchairs, Wheelchair Accessories (FDA Code: KNO), Wheelchair Armrest Covers, Wheelchair Armrest (FDA Code: IML), Bedpan (FDA Code: FOB), Wrench (FDA Code: HXC), ...
Feiter's Inc. offers wheelchair armrests, wheelchair accessories, bedpan and wrenches. more...
Phone: +1-(414)-355-7575
Products: Wheelchairs, Wheelchair Accessories (FDA Code: KNO), Wheelchair Armrest Covers, Wheelchair Armrest (FDA Code: IML), Bedpan (FDA Code: FOB), Wrench (FDA Code: HXC), ...
Feiter's Inc. offers wheelchair armrests, wheelchair accessories, bedpan and wrenches. 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: Bone Rasps (FDA Code: HTR), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Spare Hook for K Nail Extractor, Square Nail Extractor Hook, ...
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: Bone Rasps (FDA Code: HTR), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Spare Hook for K Nail Extractor, Square Nail Extractor Hook, ...
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...
Duckworth & Kent Ltd. | Address: Terence House,7 Marquis Business Centre,Royston Road,Baldock, Herts, England SG7 6XL, United Kingdom
www.duckworth-and-kent.com | Send Inquiry | Phone: +44-(1462)-893254
FDA Registration: 8021817 Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Chalazion Curettes, Crackers, Choppers, Calipers, Gauges, and Rulers, Cannulas, Titanium Microsurgical Instruments, ...
Duckworth & Kent specializes in titanium ophthalmic surgical instrumentation. We are an ISO certified company. Our products include cannulas, capsule polisher, curettes, debriders, dilators, dissector more...
www.duckworth-and-kent.com | Send Inquiry | Phone: +44-(1462)-893254
FDA Registration: 8021817 Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Chalazion Curettes, Crackers, Choppers, Calipers, Gauges, and Rulers, Cannulas, Titanium Microsurgical Instruments, ...
Duckworth & Kent specializes in titanium ophthalmic surgical instrumentation. We are an ISO certified company. Our products include cannulas, capsule polisher, curettes, debriders, dilators, dissector more...
JMF (T) Group Co., Ltd. | Address: 75/74 Moo 11, Paholyothin Rd., Klongnueng, Klongluang, Pathunthanee, TH-13 12120, Thailand
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
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: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
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...
Wellong Instruments Co., Ltd. | Address: F3, No. 1, Lane 43, Chang-An, East Rd., Sec. 1, Taipei 10442, Taiwan 
www.wellong.com.tw | Phone: +886-(2)-2571-9829
FDA Registration: 3011214569
Products: Catheters, Medical Needles, Bulb-tipped Urethral Catheter, Drainage Bag, Injection Ports, Burr Hole Cover (FDA Code: GXR), ...
Wellong Instruments Co., Ltd. designs and manufactures medical devices. We offer spinal fixation systems, shunting systems and He-Ne lasers. Our spinal fixation system includes aggregate plates, pedic more...
www.wellong.com.tw | Phone: +886-(2)-2571-9829
FDA Registration: 3011214569
Products: Catheters, Medical Needles, Bulb-tipped Urethral Catheter, Drainage Bag, Injection Ports, Burr Hole Cover (FDA Code: GXR), ...
Wellong Instruments Co., Ltd. designs and manufactures medical devices. We offer spinal fixation systems, shunting systems and He-Ne lasers. Our spinal fixation system includes aggregate plates, pedic more...
Medos S.A. | Address: Rue Girardet 29, Le Locle CH 2400, Switzerland
Phone: +41-(56)-703 333
FDA Registration: 8031062
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Burr Hole Cover (FDA Code: GXR), Shunt System Implantation Instrument (FDA Code: GYK), Central Nervous System and Components (FDA Code: JXG), ...
Medos S.A. specializes in diagnostic and therapeutic products. We provide instruments for shunt system implantation, central nervous system shunts & valves and burr hole covers. more...
Phone: +41-(56)-703 333
FDA Registration: 8031062
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Burr Hole Cover (FDA Code: GXR), Shunt System Implantation Instrument (FDA Code: GYK), Central Nervous System and Components (FDA Code: JXG), ...
Medos S.A. specializes in diagnostic and therapeutic products. We provide instruments for shunt system implantation, central nervous system shunts & valves and burr hole covers. more...
Synthes Gmbh | Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LZO), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ), Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI), Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LZO), ...
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...
Global Marketing & Business Inc. | Address: Ricardo Arias St. Advanced Tower, 1. Floor, Panama City 00000, Panama
Phone: +011-(312)-277-3454
Products: Bone Taps (FDA Code: HWX), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Bone Cap (FDA Code: JDT), Orthopedic Cutting Instrument (FDA Code: HTZ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Wrench (FDA Code: HXC), ...
Global Marketing & Business Inc. deals with orthopedic cutting instruments, orthopedic manual surgical instruments and wrenches. We also offer bone capes and tapes. more...
Phone: +011-(312)-277-3454
Products: Bone Taps (FDA Code: HWX), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Bone Cap (FDA Code: JDT), Orthopedic Cutting Instrument (FDA Code: HTZ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Wrench (FDA Code: HXC), ...
Global Marketing & Business Inc. deals with orthopedic cutting instruments, orthopedic manual surgical instruments and wrenches. We also offer bone capes and tapes. more...
Conmed International | Address: Muhammad Pura, Punjab, Sialkot, Pakistan
www.conmedint.com | Send Inquiry | Phone: +92-(52)-4291726
Products: Orthopedics Accessory Instruments, Orthopedic Surgical Instruments, Minimally Invasive Hip Instruments, Orthopedic Surgical Instruments, Osteotomes, Orthopedics Instruments, Orthopedic Instruments, Condylar Buttress Plates for Right Leg, ...
Conmed International is a manufacturer and exporter of orthopedic instruments. Our product line includes depth gauge, hexagonal screw driver, socket wrench, bending press, drill bit, angled blade plat more...
www.conmedint.com | Send Inquiry | Phone: +92-(52)-4291726
Products: Orthopedics Accessory Instruments, Orthopedic Surgical Instruments, Minimally Invasive Hip Instruments, Orthopedic Surgical Instruments, Osteotomes, Orthopedics Instruments, Orthopedic Instruments, Condylar Buttress Plates for Right Leg, ...
Conmed International is a manufacturer and exporter of orthopedic instruments. Our product line includes depth gauge, hexagonal screw driver, socket wrench, bending press, drill bit, angled blade plat more...
Himalaya Trading Co. (Pvt) Ltd. | Address: Wazirabad Road, Rai Pur, Sialkot 51051, Pakistan
himalaya-trading.com | Send Inquiry | Phone: +92-(52)-3514021
Annual Revenues: USD 100-500 Million Employee Count: ~80
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Micro Ophthalmic Scissors, Baby Ear Syringe, Ophthalmic Suture Scissors (FDA Code: HNF), ENT Irrigation Syringe (FDA Code: KCP), ...
Himalaya Trading Co. (Pvt) Ltd. is a manufacturer & exporter of surgical, dental, manicure/pedicure and veterinary instruments. We also manufacture surgical hollow ware, knives of all sorts, scissors, more...
himalaya-trading.com | Send Inquiry | Phone: +92-(52)-3514021
Annual Revenues: USD 100-500 Million Employee Count: ~80
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Micro Ophthalmic Scissors, Baby Ear Syringe, Ophthalmic Suture Scissors (FDA Code: HNF), ENT Irrigation Syringe (FDA Code: KCP), ...
Himalaya Trading Co. (Pvt) Ltd. is a manufacturer & exporter of surgical, dental, manicure/pedicure and veterinary instruments. We also manufacture surgical hollow ware, knives of all sorts, scissors, 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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
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...
U&i Corp. | Address: 529-1 Yonghyun-Dong, Euijungbu, Kyunggi-Do 480-050, Korea, Republic Of 
Phone: +82-(31)-852 0102
FDA Registration: 9617297
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
U&i Corp. deals with benders, bending/contouring instruments, bone rasps, bone taps, compression instruments and depth gauges. We also offer socket pusher, spinal interlaminal fixation, spinal interve more...
Phone: +82-(31)-852 0102
FDA Registration: 9617297
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
U&i Corp. deals with benders, bending/contouring instruments, bone rasps, bone taps, compression instruments and depth gauges. We also offer socket pusher, spinal interlaminal fixation, spinal interve 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, Digital Microscopes, Ear & Air Syringes, Surgical Needles, Reusable, Surgical Sutural Needles, Manual Stethoscope (FDA Code: LDE), ...
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, Digital Microscopes, Ear & Air Syringes, Surgical Needles, Reusable, Surgical Sutural Needles, Manual Stethoscope (FDA Code: LDE), ...
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...
Ortho Care | Address: 3 / 10 Kirti Nagar, Industrial Area, New Delhi, Delhi 110015, India
www.orthoimplants.com | Send Inquiry | Phone: +91-(11)-41424511
FDA Registration: 3007076134
Products: Hip Prosthesis, Orthopaedic Implants, External Fixators, Orthopedic Instruments, Bone Screws, Interlocking Nails, ...
Ortho Care deals with orthopaedic implants and instruments. Our products include implants, instruments, cranial maxillofacial system, modular hand implants system and sterilization boxes. Our bone scr more...
www.orthoimplants.com | Send Inquiry | Phone: +91-(11)-41424511
FDA Registration: 3007076134
Products: Hip Prosthesis, Orthopaedic Implants, External Fixators, Orthopedic Instruments, Bone Screws, Interlocking Nails, ...
Ortho Care deals with orthopaedic implants and instruments. Our products include implants, instruments, cranial maxillofacial system, modular hand implants system and sterilization boxes. Our bone scr more...
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FDA Code / Regulation: HXC / 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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