K994153 is an FDA 510(k) clearance for the CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS. This device is classified as a Prosthesis, Hip, Femoral, Resurfacing (Class II - Special Controls, product code KXA).
Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on February 25, 2000, 79 days after receiving the submission on December 8, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K994153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1999 |
| Decision Date | February 25, 2000 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| 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 |