K123907 is an FDA 510(k) clearance for the PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,. This device is classified as a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRR).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 3, 2013, 258 days after receiving the submission on December 19, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3540.
| 510(k) Number | K123907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2012 |
| Decision Date | September 03, 2013 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3540 |