K070221 is an FDA 510(k) clearance for the FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (Class III - Premarket Approval, product code KWA).
Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on April 4, 2007, 70 days after receiving the submission on January 24, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3330.
| 510(k) Number | K070221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2007 |
| Decision Date | April 04, 2007 |
| Days to Decision | 70 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 |