Kinamed Ath 22MM Cocr Total Hlip Femoral Head
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K903885 FDA 510(k)
- FDA Product Code
- KWL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3360 FDA 510(k)
- Regulation Number
- 888.3360 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Prosthesis, Hip, Hemi-, Femoral, Metal is a femoral head component for hip prostheses. It is made of cobalt chromium (CoCr) alloy and has a 22mm diameter.
This device is supplied non-sterile and is intended for single use. It is used in orthopedic hip replacement procedures and has received FDA 510(k) clearance under K903885 with product code KWL and regulation number 888.3360.
Frequently asked questions
What is the KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD used for?
This device is a femoral head component designed for hip prostheses, specifically used in orthopedic hip replacement procedures to replace the femoral head joint surface.
How is the KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD supplied and is it sterile?
The device is supplied non-sterile and is intended for single use only, meaning it must be sterilized by the healthcare provider before implantation and discarded after one procedure.
What material is the KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD made of and what is its size?
It is made of cobalt chromium (CoCr) alloy and has a 22mm diameter, as specified in the device name and description for hip prosthesis femoral head applications.
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. Sources consulted: Kinamed Ath 22mm Cocr Total Hlip Femoral Head, KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD 510(k) K903885 - fda.report, PDF K903885 - Kinamed Ath 22mm Cocr Total Hlip Femoral Head, KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL (K915309) — FDA 510(k ..., CoCr Head | Cobalt Chromium Hip Implant | Biorad Medisys
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903885 | Class II | Active |
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Manufacturer
- Manufacturer
- Kinamed, Inc.
Sources (1)
- FDA 510(k) K903885 24 fields · synced Sep 23, 2026