Greatbatch Medical, Inc.,

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Web: http://www.greatbatchmedical.com
E-Mail:
Address: 10000 Wehrle Drive, Clarence, New York 14031, USA
Phone: +1-(716)-759-5600 | Fax: +1-(716)-759-5560 | Map/Directions >>
 
 

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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• 7mm Cannulated Fragment Sets
• Acetabular Screws
• Adjustable Drill Guide
• Amputation Saws
• Angled Drivers
• Balloon Catheters
• Bender (FDA Code: HXW / 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.
• Bending Iron for Kirschner Wires
• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)
• Blades
• Bone Fixation Screw (FDA Code: HWC / 888.3040)
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
• Bone Hooks (FDA Code: KIK / 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.
• Bone Rasps (FDA Code: HTR / 878.4800)
• Bone Taps (FDA Code: HWX / 888.4540)
• Broach (FDA Code: HTQ / 888.4540)
• Cancellous Bone Screw
• Cancellous Tap
• Cannulated Sets
• Cardiac Catheters
• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500)
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
• Catheter Introducers (FDA Code: DYB / 870.1340)
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
• Compression Plate Instrument Set
• Compression Screw
• Core Reamer Set
• Cortical Screws
• Countersink (FDA Code: HWW / 888.4540)
• Cup Impactors
• DCP Drill Guide
• Dental Implants
• 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.
• Double Drill Guide
• Drill Bit (FDA Code: HTW / 888.4540)
• Drill Brace (FDA Code: HXY / 888.4540)
• Drill Guides
• Drills
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)
• Flexible Reamers System
• Forceps (FDA Code: HTD / 878.4800)
• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)
• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)
• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)
• General Surgical Instruments
• Glenoid Reamers
• Hip Screw Instrument Sets
• Holding Forceps for Small Plates
• Human Bone Rasps (FDA Code: HTR / 878.4800)
• Impactor (FDA Code: HWA / 888.4540)
• Implantable Cardiac Pacemakers
• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

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