K073637 is an FDA 510(k) clearance for the PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (Class III - Premarket Approval, product code KWA).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on March 20, 2008, 85 days after receiving the submission on December 26, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3330.
| 510(k) Number | K073637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2007 |
| Decision Date | March 20, 2008 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWA — Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3330 |