K080330 is an FDA 510(k) clearance for the SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 11, 2008, 126 days after receiving the submission on February 6, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K080330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2008 |
| Decision Date | June 11, 2008 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |