Kinamed Ath 22MM Cocr Total Hlip Femoral Head
FDA 510(k) K903885 · Kinamed, Inc.
510(k) numberK903885
Submission
- Device name
- Kinamed Ath 22MM Cocr Total Hlip Femoral Head
- Applicant
- Kinamed, Inc.
Washington, DC, US - Received
- August 21, 1990
- Decision date
- September 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Kinamed Ath 22MM Cocr Total Hlip Femoral Head cleared by the FDA?
Kinamed Ath 22MM Cocr Total Hlip Femoral Head (K903885) received a 510(k) decision of Substantially Equivalent on September 13, 1990, 23 days after the submission was received.
What is the product code of K903885?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.