K063791 is an FDA 510(k) clearance for the CORIN UNIPOLAR MODULAR HEAD. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on April 3, 2007, 102 days after receiving the submission on December 22, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K063791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2006 |
| Decision Date | April 03, 2007 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL - Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |