Orthopedic Manual Surgical Instrument Suppliers
Limit companies to: Worldwide USA
Paradigm Spine, Llc | Address: 505 Park Ave, 14th Floor, New York, New York 10022, USA 
www.paradigmspine.com | Send Inquiry | Phone: +1-(212)-583-9700
FDA Registration: 3005725110
Products: Spinal Implants, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP), Interspinous Implants, ...
Paradigm Spine, Llc is a provider of non-fusion spinal implant solutions. We offer Coflex™, an implant used in the treatment of facet arthrosis and de-compressive procedures. Our products are us more...
www.paradigmspine.com | Send Inquiry | Phone: +1-(212)-583-9700
FDA Registration: 3005725110
Products: Spinal Implants, Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB), Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP), Interspinous Implants, ...
Paradigm Spine, Llc is a provider of non-fusion spinal implant solutions. We offer Coflex™, an implant used in the treatment of facet arthrosis and de-compressive procedures. Our products are us more...
A.M. Surgical, Inc. | Address: 290 East Main St. Suite 200, Smithtown, New York 11787, USA
Phone: +1-(631)-979-9777
FDA Registration: 2437731 Year Established: 1995
Products: Sterilization Tray, Endoscopic Suturing Devices (FDA Code: MFJ), Surgical Tables Accessories, Arm Protection Support, Manual Operating Room Table (FDA Code: FSE), Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT), Surgical Knife (FDA Code: EMF), ...
A.M. Surgical, Inc. develops and distributes invasive devices and surgical procedures. Our products include cross pin fixator for distal radius fractures, uniportal endoscopic carpal tunnel release, u more...
Phone: +1-(631)-979-9777
FDA Registration: 2437731 Year Established: 1995
Products: Sterilization Tray, Endoscopic Suturing Devices (FDA Code: MFJ), Surgical Tables Accessories, Arm Protection Support, Manual Operating Room Table (FDA Code: FSE), Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT), Surgical Knife (FDA Code: EMF), ...
A.M. Surgical, Inc. develops and distributes invasive devices and surgical procedures. Our products include cross pin fixator for distal radius fractures, uniportal endoscopic carpal tunnel release, u more...
New England Medical Corp. | Address: 2274 Albany Post Rd., Walden, New York 12586, USA
Phone: +1-(845)-778-4200
Products: Electrode Cables (FDA Code: IKD), Gas Cylinder Pressure Regulator (FDA Code: CAN), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument Kit (FDA Code: KDD), Gynecologic Electrocautery and Accessories (FDA Code: HGI), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
New England Medical Corp deals with surgical instruments. Our products include electrosurgical accessories, disposable surgical instruments, gas cylinder pressure regulators, pressure infusor for IV b more...
Phone: +1-(845)-778-4200
Products: Electrode Cables (FDA Code: IKD), Gas Cylinder Pressure Regulator (FDA Code: CAN), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument Kit (FDA Code: KDD), Gynecologic Electrocautery and Accessories (FDA Code: HGI), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
New England Medical Corp deals with surgical instruments. Our products include electrosurgical accessories, disposable surgical instruments, gas cylinder pressure regulators, pressure infusor for IV b more...
Atrium, Inc. | Address: 21225 Se Walgren Rd, Damascus, Oregon 97089, USA
Products: General Surgical Manual Instrument (FDA Code: MDM), Non-Powered Surgical Instrument (FDA Code: HAO), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Atrium, Inc. specializes in general surgical manual instrument and orthopedic manual surgical instruments. more...
Products: General Surgical Manual Instrument (FDA Code: MDM), Non-Powered Surgical Instrument (FDA Code: HAO), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Atrium, Inc. specializes in general surgical manual instrument and orthopedic manual surgical instruments. more...
Medisiss | Address: 2747 Sw 6th Street, Redmond, Oregon 97756, USA
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab 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: 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...
Precision Medical Products, Inc. | Address: 44 Denver Road, PO Box 300, Denver, Pennsylvania 17517, USA
www.pmp.net | Send Inquiry | Phone: +1-(717)-335-3700
FDA Registration: 2531321 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~140 Quality: ISO 13485:2003, CE Certified
Products: Hypodermic Syringes, Infusion Therapy Kits, Arthroscopic Equipment, Spinal Implants, Radio pharmaceutical Products, Syringe Injector, ...
Precision Medical Products, Inc. specializes in engineering, manufacturing and packaging of original equipment manufacturer (OEM) medical devices. Our product categories are bifurcated needles, drug d more...
www.pmp.net | Send Inquiry | Phone: +1-(717)-335-3700
FDA Registration: 2531321 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~140 Quality: ISO 13485:2003, CE Certified
Products: Hypodermic Syringes, Infusion Therapy Kits, Arthroscopic Equipment, Spinal Implants, Radio pharmaceutical Products, Syringe Injector, ...
Precision Medical Products, Inc. specializes in engineering, manufacturing and packaging of original equipment manufacturer (OEM) medical devices. Our product categories are bifurcated needles, drug d more...
Mark Medical Manufacturing, Inc. | Address: 530 Brandywine Ave., Downingtown, Pennsylvania 19335, USA
www.markmed.com | Send Inquiry | Phone: +1-(610)-269-4420
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Biopsy Forceps, Cervical Dilator, Endocervical Curettes, Cardiovascular Surgical Instrument (FDA Code: DWS), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Mark Medical Manufacturing, Inc. is a manufacturer and supplier of surgical instruments. Our gynecology products include stainless steel specula, vaginal retractors, cervical dilators, biopsy forceps, more...
www.markmed.com | Send Inquiry | Phone: +1-(610)-269-4420
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Biopsy Forceps, Cervical Dilator, Endocervical Curettes, Cardiovascular Surgical Instrument (FDA Code: DWS), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Mark Medical Manufacturing, Inc. is a manufacturer and supplier of surgical instruments. Our gynecology products include stainless steel specula, vaginal retractors, cervical dilators, biopsy forceps, more...
Medartis, Inc. | Address: 127 W Street Road, Suite 203, Kennett Square, Pennsylvania 19348, USA
www.medartis.com | Phone: +1-(610)-961-6101, 877-406-2663
FDA Registration: 3005215824
Products: Locking Phalangeal Forceps, Drill Bit (FDA Code: HTW), Distal Radius Plating System, Bone Fixation Screw (FDA Code: HWC), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Medartis, Inc. offers solutions in the area of medical technology for surgical fixation, correction and reconstruction of extremities & facial skeleton. We provide surgeons and operating theater perso more...
www.medartis.com | Phone: +1-(610)-961-6101, 877-406-2663
FDA Registration: 3005215824
Products: Locking Phalangeal Forceps, Drill Bit (FDA Code: HTW), Distal Radius Plating System, Bone Fixation Screw (FDA Code: HWC), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Medartis, Inc. offers solutions in the area of medical technology for surgical fixation, correction and reconstruction of extremities & facial skeleton. We provide surgeons and operating theater perso more...
Core Essence Orthopaedics, Inc | Address: 301 Oxford Valley Rd., Suite 905b, Lower Makefield, Pennsylvania 19067, USA
www.ceortho.com | Send Inquiry | Phone: +1-(215)-310-9534
Products: Suture Anchors, Monofilament & Multifilament Steel Non-Absorbable Suture (FDA Code: GAQ), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Bone Fixation Screw (FDA Code: HWC), Bone Fixation Staple (FDA Code: JDR), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), ...
Core Essence Orthopaedics, Inc manufactures surgical products. Our products include reNOVO™ suture anchor system, reVERTO™ shape memory staple system, Seg-Way™ synchronized endoscopi more...
www.ceortho.com | Send Inquiry | Phone: +1-(215)-310-9534
Products: Suture Anchors, Monofilament & Multifilament Steel Non-Absorbable Suture (FDA Code: GAQ), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Bone Fixation Screw (FDA Code: HWC), Bone Fixation Staple (FDA Code: JDR), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), ...
Core Essence Orthopaedics, Inc manufactures surgical products. Our products include reNOVO™ suture anchor system, reVERTO™ shape memory staple system, Seg-Way™ synchronized endoscopi more...
Suretek Medical | Address: 25-B Maple Creek Circle, Greenville, South Carolina 29607, USA
www.suretekmedical.com | Phone: +1-(864)-299 9743
FDA Registration: 3005575604 Quality: ISO 14971:2000, 11135:1994, 11607-1 Certified
Products: Bone Rasps (FDA Code: HTR), Compressible Limb Sleeve (FDA Code: JOW), General & Plastic Saw Surgical Blade (FDA Code: GFA), General Surgical Manual Instrument (FDA Code: MDM), Arthroscopic Accessories (FDA Code: NBH), Gynecologic Laparoscopic Accessories (FDA Code: NWV), ...
Suretek Medical provides surgical reprocessing services. We reprocess a range of single-use devices for hand, arthroscopy, laparoscopy, otolayrngology, gynecology and general surgery. Our frequently r more...
www.suretekmedical.com | Phone: +1-(864)-299 9743
FDA Registration: 3005575604 Quality: ISO 14971:2000, 11135:1994, 11607-1 Certified
Products: Bone Rasps (FDA Code: HTR), Compressible Limb Sleeve (FDA Code: JOW), General & Plastic Saw Surgical Blade (FDA Code: GFA), General Surgical Manual Instrument (FDA Code: MDM), Arthroscopic Accessories (FDA Code: NBH), Gynecologic Laparoscopic Accessories (FDA Code: NWV), ...
Suretek Medical provides surgical reprocessing services. We reprocess a range of single-use devices for hand, arthroscopy, laparoscopy, otolayrngology, gynecology and general surgery. Our frequently r more...
Six-O, Ltd. | Address: 4901 Copperhill Drive, Rapid City, South Dakota 57702, USA
Phone: +1-(605)-341-0284
Products: Orthopedic Surgery Service, Orthopedic Implant Material (FDA Code: MOO), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Six-O, Ltd. focuses on autogenous bone catchers. We offer orthopedic manual surgical instruments. more...
Phone: +1-(605)-341-0284
Products: Orthopedic Surgery Service, Orthopedic Implant Material (FDA Code: MOO), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Six-O, Ltd. focuses on autogenous bone catchers. We offer orthopedic manual surgical instruments. more...
Chattanooga Group | Address: 4717 Adams Road, Hixson, Tennessee 37343, USA
www.chattgroup.com | Phone: +1-(423)-870.2281, 800.592.7329
Year Established: 1947 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Carts, Chairs & stools, Compression Garments, Cryosurgery, EKG Supplies, Exam Tables, ...
Chattanooga Group produces rehabilitation equipment for treating skeletal, muscular, neurological and soft tissue disorders. Our laser therapy uses light to penetrate tissue for increased blood flow a more...
www.chattgroup.com | Phone: +1-(423)-870.2281, 800.592.7329
Year Established: 1947 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Carts, Chairs & stools, Compression Garments, Cryosurgery, EKG Supplies, Exam Tables, ...
Chattanooga Group produces rehabilitation equipment for treating skeletal, muscular, neurological and soft tissue disorders. Our laser therapy uses light to penetrate tissue for increased blood flow a more...
Choice Spine, LP | Address: 306 Erin Dr., Knoxville, Tennessee 37919, USA
www.choicespine.net | Send Inquiry | Phone: +1-(865)-246 3333
FDA Registration: 3005819474 Year Established: 2006
Products: Bone Taps (FDA Code: HWX), Periodontal Probes, Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Choice Spine, LP offers orthopedic & neurosurgical products which focus on the treatment of spinal disorders and deformities through operative intervention. Omniaxial connector, choicespine claris is more...
www.choicespine.net | Send Inquiry | Phone: +1-(865)-246 3333
FDA Registration: 3005819474 Year Established: 2006
Products: Bone Taps (FDA Code: HWX), Periodontal Probes, Orthopedic Manual Surgical Instrument (FDA Code: LXH), Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Choice Spine, LP offers orthopedic & neurosurgical products which focus on the treatment of spinal disorders and deformities through operative intervention. Omniaxial connector, choicespine claris is more...
Memometal Inc | Address: 6000 Poplar Avenue, Suite 110, Mem, Tennessee 38119, USA
www.mmi-usa.com | Phone: +1-(866)-682-7577
Products: Orthopaedic Implants, Compression Screw, Bone Fixation Screw (FDA Code: HWC), Bone Fixation Staple (FDA Code: JDR), Smooth Fixation Pin (FDA Code: HTY), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), ...
Memometal Inc manufactures surgical implants for extremities. We offer surgical implants that include foot and ankle & hand and wrist products. Our foot and ankle products inlcude Easyclip™ SI, more...
www.mmi-usa.com | Phone: +1-(866)-682-7577
Products: Orthopaedic Implants, Compression Screw, Bone Fixation Screw (FDA Code: HWC), Bone Fixation Staple (FDA Code: JDR), Smooth Fixation Pin (FDA Code: HTY), Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI), ...
Memometal Inc manufactures surgical implants for extremities. We offer surgical implants that include foot and ankle & hand and wrist products. Our foot and ankle products inlcude Easyclip™ SI, more...
In'Tech Medical, Incorporated | Address: 2851, Lamb Place, Suite 15, Memphis, Tennessee 38118, USA
Phone: +1-(901)-375-1109
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Calipers (FDA Code: KTZ), Orthopedic Elevator (FDA Code: HTE), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
In'Tech Medical, Incorporated specializes in providing surgical curettes, calipers and orthopedic elevators. more...
Phone: +1-(901)-375-1109
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Calipers (FDA Code: KTZ), Orthopedic Elevator (FDA Code: HTE), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
In'Tech Medical, Incorporated specializes in providing surgical curettes, calipers and orthopedic elevators. 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), Surgical Retractor (FDA Code: GAD), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), Drill Brace (FDA Code: HXY), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
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), Surgical Retractor (FDA Code: GAD), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), Drill Brace (FDA Code: HXY), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
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...
Arthrocare Corporation | Address: 7500 Rialto Boulevard, Building Two, Suite 100, Austin, Texas 78735, USA
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Vertebroplasty, Bone Cement (FDA Code: LOD), Ear & Hearing Protection, Goggles & Protective Eyewear, Calcium Phosphate Bone Cements, Bioreabsorbable Bone Cement, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Vertebroplasty, Bone Cement (FDA Code: LOD), Ear & Hearing Protection, Goggles & Protective Eyewear, Calcium Phosphate Bone Cements, Bioreabsorbable Bone Cement, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
Genesys Spine | Address: 1250 Capital Of Texas Highway South, Building Three, Suite 600, Austin, Texas 78746, USA
FDA Registration: 3008455034
Products: Medical Probes (FDA Code: HXB), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Surgical Pliers (FDA Code: HTC), ...
Genesys Spine is a provider of orthopedic surgical manual instruments including pliers and probes. more...
FDA Registration: 3008455034
Products: Medical Probes (FDA Code: HXB), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Surgical Pliers (FDA Code: HTC), ...
Genesys Spine is a provider of orthopedic surgical manual instruments including pliers and probes. more...
Encore Medical, L.P. | Address: 9800 Metric Blvd., Austin, Texas 78758, USA
www.djosurgical.com | Phone: +1-(512)-832-9500, 800-456-8696
FDA Registration: 1644408
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Orthopedic Burr (FDA Code: HTT), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Prosthesis Driver (FDA Code: HWR), ...
Encore Medical, L.P. is a designer, manufacturer and distributor of orthopedic surgery products. Our Reverse® shoulder prosthesis is indicated for use in patients with a functional deltoid muscle, more...
www.djosurgical.com | Phone: +1-(512)-832-9500, 800-456-8696
FDA Registration: 1644408
Products: Drill Bit (FDA Code: HTW), Nail Extractors (FDA Code: HWB), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Orthopedic Burr (FDA Code: HTT), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Prosthesis Driver (FDA Code: HWR), ...
Encore Medical, L.P. is a designer, manufacturer and distributor of orthopedic surgery products. Our Reverse® shoulder prosthesis is indicated for use in patients with a functional deltoid muscle, more...
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FDA Code / Regulation: LXH / 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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