K071053 is an FDA 510(k) clearance for the RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD. This device is classified as a Prosthesis, Hip, Femoral, Resurfacing (Class II - Special Controls, product code KXA).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 29, 2007, 77 days after receiving the submission on April 13, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K071053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2007 |
| Decision Date | June 29, 2007 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KXA — Prosthesis, Hip, Femoral, Resurfacing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3400 |