The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Prelude Pf Patellae.
| Device ID | K143543 |
| 510k Number | K143543 |
| Device Name: | Prelude PF Patellae |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Jared Cooper |
| Correspondent | Jared Cooper BIOMET INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-01-30 |
| Summary: | summary |