150MM COCR Bimetric Head/Neck Replacement Hip Stem - Color Buff Finish
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K983710 FDA 510(k)
- FDA Product Code
- JDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3350 FDA 510(k)
- Regulation Number
- 888.3350 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 150MM COCR Bimetric Head/Neck Replacement Hip Stem is an orthopedic implant device used for hip replacement surgery. It is designed to replace the femoral head and neck portion of the hip joint, providing structural support and mobility for patients with hip joint damage or degeneration.
This device is supplied in a color buff finish and is available in the 150MM size. It is authorized under FDA 510K clearance with product code JDI. The device is manufactured by Biomet, Inc. and is intended for use in orthopedic surgical procedures as a hip stem component.
Frequently asked questions
What is the 150MM COCR Bimetric Hip Stem used for?
The 150MM COCR Bimetric Head/Neck Replacement Hip Stem is an orthopedic implant device used in hip replacement surgery to replace the femoral head and neck portion of the hip joint, providing structural support and mobility for patients with hip joint damage or degeneration.
What are the specifications of this hip stem implant?
This device is available in a 150MM size with a color buff finish. It is manufactured by Biomet, Inc. and is designed as a hip stem component for orthopedic surgical procedures. The device has product code JDI and is authorized under FDA 510K clearance.
Is this device single-use or reusable?
The device information does not specify whether this hip stem is single-use or reusable. For proper usage instructions and disposal guidelines, please refer to the manufacturer's documentation or consult with a healthcare professional familiar with this specific implant.
What is the regulatory status of this hip stem implant?
The 150MM COCR Bimetric Head/Neck Replacement Hip Stem is authorized under FDA 510K clearance with product code JDI. It received FDA clearance on December 2, 1998, and was determined to be substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983710 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K983710 24 fields · synced Sep 21, 2026