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Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics |
Send Inquiry |
Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977
Annual Revenues: > USD 1 Billion
Employee Count: ~20
Quality: ISO 9001, CE Certified
Products: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code:
HTD), Probes (FDA Code:
HXB), Saws (FDA Code:
HSO), ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company.
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Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com |
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Phone: +1-(508)-835-9700
Year Established: 1981
Annual Revenues: USD 10-25 Million
Employee Count: ~140
Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code:
HDL), Forceps (FDA Code:
HTD), Probes (FDA Code:
HXB), Light Sources, Visual Acuity Charts (FDA Code:
HOX), Surgical Headlights, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito
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Address: 71 Jay Avenue,Teesside Industrial Estate, Thornaby, Cleveland TS17 9LZ, United Kingdom
www.implantsinternational.com |
Send Inquiry |
Phone: +44-(1642)-769080
Quality: ISO 9001, CE, ISO 13485 Certified
Products: Forceps (FDA Code:
HTD), Total Shoulder Systems, Primary Femoral Implants, Primary Shell/Cup Systems, Bone Cement (FDA Code:
LOD), Total Knee Systems, ...
Implants International Ltd. is a pro-active bio-engineering company that specializes in the arthroplasty, trauma & spinal implant sectors. We are an ISO certified company. Our implants range comprises
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FDA Code / Regulation: JWI / 888.3800 A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
Classification. Class II.