K073499 is an FDA 510(k) clearance for the VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III - Premarket Approval, product code JDL).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 7, 2008, 238 days after receiving the submission on December 13, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.
| 510(k) Number | K073499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2007 |
| Decision Date | August 07, 2008 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| 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 |