Profile: Zhejiang Biomet Medical Products Co., Ltd. offers orthopedic and arthritis products. Our Oxford™ partial knee implant is an implant designed to repair only one side of the knee. Our product removes less bone & cartilage and provides natural motion. It has an artificial meniscal bearing, which is designed to glide freely throughout the knee's range of motion. Our Taperloc® hip system offers three stem options to address an individual femoral canal. It is designed to accommodate individual anatomy.
FDA Registration Number: 3006801265
US Agent: Holly Seppanen / Zimmer Biomet
Phone: +1-(952)-847-0494 E-Mail:
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• Awl (FDA Code: HWJ / 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. |
• Bender (FDA Code: HXW / 888.4540) |
• Bone Fixation Plate (FDA Code: HRS / 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. |
• Bone Mallets (FDA Code: HXL / 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 Mill (FDA Code: LYS / 888.4540) |
• Bone Rasps (FDA Code: HTR / 878.4800) |
• Bone Taps (FDA Code: HWX / 888.4540) |
• Broach (FDA Code: HTQ / 888.4540) |
• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis. |
• 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. |
• Drill Bit (FDA Code: HTW / 888.4540) |
• Femoral Neck Punch (FDA Code: HWP / 888.4540) |
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300) |
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800) |
• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800) |
• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800) |
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) |
• Guiding Probes |
• Human Bone Rasps (FDA Code: HTR / 878.4800) |
• Impactor (FDA Code: HWA / 888.4540) |
• Instrument Surgical Guide (FDA Code: FZX / 878.4800) |
• Laparoscopic Probes |
• Laser Power Probe |
• Manual Surgical Chisel (FDA Code: FZO / 878.4800) |
• Medical Probes (FDA Code: HXB / 888.4540) |
• Medical Rasps (FDA Code: HTR / 878.4800) |
• Metallic Bone Fixation Nail (FDA Code: NDH / 888.3030) |
• Metallic Non-Spinal Bone Fixation Plate (FDA Code: NDF / 888.3030) |
• Nail Extractors (FDA Code: HWB / 888.4540) |
• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800) |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
• Periodontal Probes |
• Pin Surgical Driver (FDA Code: GFC / 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. |
• Probes (FDA Code: HXB / 888.4540) |
• Probes (FDA Code: HXB / 888.4540) |
• Prosthesis Alignment Device (FDA Code: IQO / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint. |
• Prosthesis Driver (FDA Code: HWR / 888.4540) |
• Reamer (FDA Code: HTO / 888.4540) |
• Screwdriver (FDA Code: HXX / 888.4540) |
• Small Depth Gauge (FDA Code: HTJ / 888.4300) |
• Socket Pusher (FDA Code: HXO / 888.4540) |
• Surgical Cutter (FDA Code: FZT / 878.4800) |
• Surgical Hammer (FDA Code: FZY / 878.4800) |
• Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Tamps (FDA Code: HXG / 888.4540) |
• Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting. |
• Wire Cutters (FDA Code: HXZ / 888.4540) |
• Wrench (FDA Code: HXC / 888.4540) |