Compression Instrument Suppliers
Limit companies to: Worldwide USA
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...
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...
Bk Meditech Co., Ltd. | Address: #607 Instopia Bldg, Dokok Dong, Kangnam-ku, Seoul 467-23, Korea, Republic Of
www.bkmeditech.com | Phone: +82-(31)-3529135
FDA Registration: 3004176895
Products: Bone Taps (FDA Code: HWX), Laparoscopic Probes, Guiding Probes, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Compression Instrument (FDA Code: HWN), ...
Bk Meditech Co., Ltd. manufactures orthopaedic implants. Our products are Dyna spine, Dyna Extor arm, Dyna Extor finger, Dyna Extor limb and Dyna Extor wrist systems. Our Dyna spinal system features a more...
www.bkmeditech.com | Phone: +82-(31)-3529135
FDA Registration: 3004176895
Products: Bone Taps (FDA Code: HWX), Laparoscopic Probes, Guiding Probes, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Compression Instrument (FDA Code: HWN), ...
Bk Meditech Co., Ltd. manufactures orthopaedic implants. Our products are Dyna spine, Dyna Extor arm, Dyna Extor finger, Dyna Extor limb and Dyna Extor wrist systems. Our Dyna spinal system features a more...
Electronic Instruments & Systems S.R.L. | Address: via Monterosso al Mare, 7, Rome 00168, Italy
www.elis.it | Send Inquiry | Phone: 0039 06 6281333
Year Established: 1975 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Diabetes Test Strips, Water Quality Test Strips, Alpha-Fetoprotein Rapid Test Strip, Amphetamine Test Strip, Sugar Monitoring Test Strip, Insulin Test Strip, ...
Electronic Instruments & Systems S.R.L. specializes in offering dynamometers, machines, tools and systems for testing materials & finished products. The dynamometers are designed to measure the IMADA more...
www.elis.it | Send Inquiry | Phone: 0039 06 6281333
Year Established: 1975 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Diabetes Test Strips, Water Quality Test Strips, Alpha-Fetoprotein Rapid Test Strip, Amphetamine Test Strip, Sugar Monitoring Test Strip, Insulin Test Strip, ...
Electronic Instruments & Systems S.R.L. specializes in offering dynamometers, machines, tools and systems for testing materials & finished products. The dynamometers are designed to measure the IMADA 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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
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: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
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...
Raimund Wenzler GmbH, Instrumenten-Manufaktur | Address: Steigacker 22, Balgheim 78582, Germany 
Phone: +49-(497)-4249582730
FDA Registration: 9611616
Products: Uterine Curettes (FDA Code: HCY), Cervical Thoracic Orthosis (FDA Code: IPT), ENT Forceps (FDA Code: KAE), Thoracic Orthosis, Brace (FDA Code: IPT), Gynecological Biopsy Forceps (FDA Code: HFB), Nasal Rongeur (FDA Code: KBB), ...
Raimund Wenzler GmbH, Instrumenten-Manufaktur specializes in providing bone rongeur forceps, forceps for gynecology, ear, nose & throat surgical instruments, orthopedic cutting instruments and surgica more...
Phone: +49-(497)-4249582730
FDA Registration: 9611616
Products: Uterine Curettes (FDA Code: HCY), Cervical Thoracic Orthosis (FDA Code: IPT), ENT Forceps (FDA Code: KAE), Thoracic Orthosis, Brace (FDA Code: IPT), Gynecological Biopsy Forceps (FDA Code: HFB), Nasal Rongeur (FDA Code: KBB), ...
Raimund Wenzler GmbH, Instrumenten-Manufaktur specializes in providing bone rongeur forceps, forceps for gynecology, ear, nose & throat surgical instruments, orthopedic cutting instruments and surgica more...
aap Biomaterials GmbH | Address: Lagerstr. 11-15, Dieburg D-64807, Germany
www.aap.de | Send Inquiry | Phone: +49-(6071)-929-0
FDA Registration: 9615014
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Impactor (FDA Code: HWA), Screwdriver (FDA Code: HXX), Wrench (FDA Code: HXC), ...
aap Biomaterials GmbH specializes in developing, manufacturing and marketing implants & biomaterials for trauma & joint reconstruction. Our product portfolio includes implants for fracture healing and more...
www.aap.de | Send Inquiry | Phone: +49-(6071)-929-0
FDA Registration: 9615014
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Impactor (FDA Code: HWA), Screwdriver (FDA Code: HXX), Wrench (FDA Code: HXC), ...
aap Biomaterials GmbH specializes in developing, manufacturing and marketing implants & biomaterials for trauma & joint reconstruction. Our product portfolio includes implants for fracture healing and 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: Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Y-Stent Forceps, ENT Forceps (FDA Code: KAE), Electrosurgical Electrode (FDA Code: JOS), ...
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: Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Y-Stent Forceps, ENT Forceps (FDA Code: KAE), Electrosurgical Electrode (FDA Code: JOS), ...
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...
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: 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), Nose And Throat Ear Bur (FDA Code: EQJ), ...
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: 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), Nose And Throat Ear Bur (FDA Code: EQJ), ...
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...
Marida, Marianne Daniels Chir. Instr. | Address: Doenhoffstrasse 6, Solingen 42655, Germany
Phone: +49-(212)-81 22 25
FDA Registration: 9680059
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Chisel/Osteotome (FDA Code: KDG), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), Calipers (FDA Code: KTZ), ...
Marida, Marianne Daniels Chir. Instr. deals with surgical scissors, needle holder, surgical clamp and various plastic surgery products. more...
Phone: +49-(212)-81 22 25
FDA Registration: 9680059
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Chisel/Osteotome (FDA Code: KDG), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), Calipers (FDA Code: KTZ), ...
Marida, Marianne Daniels Chir. Instr. deals with surgical scissors, needle holder, surgical clamp and various plastic surgery products. more...
Friedrich Daniels Gmbh | Address: Donhoffstr. 6, Solingen 42655, Germany
www.friedrich-daniels.com | Send Inquiry | Phone: +49-(212)-810050
FDA Registration: 9611390
Products: Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Artery Vascular Clamp (FDA Code: DXC), Bending/Contouring Instrument (FDA Code: HXP), Bone Skid (FDA Code: HWO), Bladder Neck Spreader (FDA Code: FHK), ...
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: Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Artery Vascular Clamp (FDA Code: DXC), Bending/Contouring Instrument (FDA Code: HXP), Bone Skid (FDA Code: HWO), Bladder Neck Spreader (FDA Code: FHK), ...
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...
Diwymed Production Gmbh | Address: By Hassler 5, Tuttlingen 78532, Germany
Send Inquiry | Phone: +49-(7462)-200116
FDA Registration: 9680938
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), ...
Diwymed Production Gmbh offers surgical retractors, probes, pliers, surgical hammers, retainers, medical rasps and bone hooks. more...
Send Inquiry | Phone: +49-(7462)-200116
FDA Registration: 9680938
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), ...
Diwymed Production Gmbh offers surgical retractors, probes, pliers, surgical hammers, retainers, medical rasps and bone hooks. more...
Erchinger Medizintecnik | Address: Rudolf-Diesel-Str. 20, Tuttlingen 78532, Germany
Phone: +49-(7461)-3243
FDA Registration: 9611827
Products: ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Nasal Rasps (FDA Code: KBA), Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Erchinger Medizintecnik specializes in offering hemorrhoidal suction ligators. Our products include ENT injection syringes, urological catheters, ENT suction tube, surgical needle guides, trocars for more...
Phone: +49-(7461)-3243
FDA Registration: 9611827
Products: ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Nasal Rasps (FDA Code: KBA), Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Erchinger Medizintecnik specializes in offering hemorrhoidal suction ligators. Our products include ENT injection syringes, urological catheters, ENT suction tube, surgical needle guides, trocars for more...
Aesculap Ag | Address: 1120, Tuttlingen, Donau D-78532, Germany
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
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), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
www.aesculap.de | Send Inquiry | Phone: +94-(610)-9849074
FDA Registration: 9610612
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), ...
Aesculap Ag offers instruments for minimal invasive surgery. Our product range includes surgical instruments for open or minimally invasive approaches, implants for orthopedic, neuro and spinal surger more...
MAT | Address: Friedrich-Woehler-Str. 10, Emmingen-Liptingen, DE-BW 78576, Germany
www.mat-medical.com | Send Inquiry | Phone: +49-(7465)-909 188
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Manual Surgical Chisel (FDA Code: FZO), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
MAT designs, develops, and manufactures implants for implant systems. We make orthopedic implants used primarily in knee and hip implant systems. We provide a broad range of trauma and dental implants more...
www.mat-medical.com | Send Inquiry | Phone: +49-(7465)-909 188
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Manual Surgical Chisel (FDA Code: FZO), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
MAT designs, develops, and manufactures implants for implant systems. We make orthopedic implants used primarily in knee and hip implant systems. We provide a broad range of trauma and dental implants more...
CM Instrumente GmbH | Address: Im Gänsäcker 56, Tuttlingen, Deutschland 78532, Germany
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
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), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
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), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
Lifecare Surgical | Address: Nasr City Free Industrial Zone, Area 3, Block B, Nasr City 11816, Egypt
www.lifecaresi.com | Send Inquiry | Phone: +20-(2)-26720314
Quality: ISO 13485:2003 Certified
Products: Adenoid Curettes (FDA Code: KBJ), Adenoid Punches (FDA Code: KBS), Antrum Punch (FDA Code: KAW), Amputation Knife (FDA Code: GDN), Awl (FDA Code: HWJ), Attic Punch (FDA Code: JYX), ...
Lifecare Surgical focuses on general surgical, dental, veterinary, and electro surgical instruments. We provide knives, scalpels, suture, forceps, probes, spatula, cotton carriers, suction tubes, and more...
www.lifecaresi.com | Send Inquiry | Phone: +20-(2)-26720314
Quality: ISO 13485:2003 Certified
Products: Adenoid Curettes (FDA Code: KBJ), Adenoid Punches (FDA Code: KBS), Antrum Punch (FDA Code: KAW), Amputation Knife (FDA Code: GDN), Awl (FDA Code: HWJ), Attic Punch (FDA Code: JYX), ...
Lifecare Surgical focuses on general surgical, dental, veterinary, and electro surgical instruments. We provide knives, scalpels, suture, forceps, probes, spatula, cotton carriers, suction tubes, and more...
EDLO S/A Produtos Médicos | Address: 751,Berto Cirio Street, Canoas 92420-030, Brazil
www.edlo.com.br | Phone: +55-(51)-3052-3904
FDA Registration: 8043769
Products: Tongue Depressors (FDA Code: FMA), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), ENT Elevator (FDA Code: KAD), Non-Sterile Ent Wire Cutting Scissors (FDA Code: NNU), ...
EDLO S/A Produtos Médicos specializes in offering Sitracc (Single Switch Access) single access platform. It features significant reduction of pain and length of stay & aesthetic, and the absence of sc more...
www.edlo.com.br | Phone: +55-(51)-3052-3904
FDA Registration: 8043769
Products: Tongue Depressors (FDA Code: FMA), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), ENT Elevator (FDA Code: KAD), Non-Sterile Ent Wire Cutting Scissors (FDA Code: NNU), ...
EDLO S/A Produtos Médicos specializes in offering Sitracc (Single Switch Access) single access platform. It features significant reduction of pain and length of stay & aesthetic, and the absence of sc more...
I.T.S. Gmbh | Address: Autal 28, Lassnitzhoehe A-8301, Austria
FDA Registration: 3004369035
Products: Drill Bit (FDA Code: HTW), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Compression Instrument (FDA Code: HWN), Threaded Fixation Pin (FDA Code: JDW), Nut Bolt Washer (FDA Code: HTN), ...
I.T.S. Gmbh deals with surgical equipments like bone fixation screws, bone fixation nails, intramedullary fixation rods and metallic non-spinal bone fixation plates. We also offer metallic non-spinal more...
FDA Registration: 3004369035
Products: Drill Bit (FDA Code: HTW), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Compression Instrument (FDA Code: HWN), Threaded Fixation Pin (FDA Code: JDW), Nut Bolt Washer (FDA Code: HTN), ...
I.T.S. Gmbh deals with surgical equipments like bone fixation screws, bone fixation nails, intramedullary fixation rods and metallic non-spinal bone fixation plates. We also offer metallic non-spinal more...
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FDA Code / Regulation: HWN / 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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