K030205 is an FDA 510(k) clearance for the CONSENSUS UNIPOLAR HEAD, COCR. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on April 1, 2003, 70 days after receiving the submission on January 21, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K030205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2003 |
| Decision Date | April 01, 2003 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |