KYK — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite Class II
FDA product code KYK covers "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite", a Class II medical device regulated under 21 CFR 888.3500. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KYK
- Device Class
- Class II
- Regulation Number
- 888.3500
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes