K004043 is an FDA 510(k) clearance for the METAL TRANSCEND ARTICULATION SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III - Premarket Approval, product code JDL).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 13, 2001, 196 days after receiving the submission on December 29, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.
| 510(k) Number | K004043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2000 |
| Decision Date | July 13, 2001 |
| Days to Decision | 196 days |
| Submission Type | Abbreviated |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3320 |