K042973 is an FDA 510(k) clearance for the SOLITUDE UNIPOLAR HEAD. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on January 27, 2005, 91 days after receiving the submission on October 28, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K042973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2004 |
| Decision Date | January 27, 2005 |
| Days to Decision | 91 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 |