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Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics |
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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: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
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: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
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 |
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Phone: +44-(1642)-769080
Quality: ISO 9001, CE, ISO 13485 Certified
Products: Total Shoulder Systems, Primary Femoral Implants, Primary Shell/Cup Systems, Total Knee Systems, Hip Replacement, Femoral Heads, Acetabular Cup System, ...
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.