KRP — Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal Class III
FDA product code KRP covers "Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal", a Class III medical device regulated under 21 CFR 888.3550. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- KRP
- Device Class
- Class III
- Regulation Number
- 888.3550
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96