Profile: Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly includes batteries, capacitors, pacing leads which is composed of permanent, sutureless, epicardial leads (Enpath™ MyoPore) and an innovative implant tool (Enpath FasTac), hermetic Hittman™ feedthroughs for the implantable medical device industry, & precision metal forming and micromolding. We provide hip replacement, fracture fixation implants, spine fixation instruments, & implant cases and trays. Our delivery systems enhance the visual presentation with help of screen-printing graphic artwork. It includes precimed® line of reamers and handles.

The company is ISO 13485 certified.

FDA Registration Number: 3004976965

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• Interference Screws

• Intermediate Bone Screws

• Lag Screws

• Lighted Retractors

• Liner Impactors

• Malleolar Bone Screws

• Medical Rasps (FDA Code: HTR / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Mini Fragment Sets

• MIS Reamers

• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Nail Extractors (FDA Code: 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.

• Nails & Screws

• Orthopaedic Implants

• Orthopedic Burr (FDA Code: HTT / 888.4540)

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Instruments

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)

• Pacemaker Lead Adaptor (FDA Code: DTD / 870.3620) A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.

• Patella Reamers

• Pedicle Screw System

• Pedicle Screws

• Percutaneous Catheter (FDA Code: DQY / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

• Periosteal Elevator

• Peripheral Reamer Set

• Permanent Cardiac Pacemaker (FDA Code: DTB / 870.3680) A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Reamer (FDA Code: HTO / 888.4540)

• Reamer Trays

• Retractor Trays

• Rods & Plates

• Saws (FDA Code: HSO / 878.4800)

• Saws Instruments

• Screwdriver (FDA Code: HXX / 888.4540)

• Screwdrivers & Torques

• Self-Holding Screw Forceps

• Self-Tapping Screws

• Shoulder Retractor Sets

• Small Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Small Fragment Sets

• Spine Implants

• Steerable Sheaths

• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Straight Broach Handles

• Surgical Cutter (FDA Code: FZT / 878.4800)

• Surgical Drills

• Surgical Drills & Reamers

• Surgical Equipment, Blades & Burrs

• Surgical Hand Pieces