The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series.
| Device ID | K073499 |
| 510k Number | K073499 |
| Device Name: | VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Eric S Pittman |
| Correspondent | Eric S Pittman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-13 |
| Decision Date | 2008-08-07 |
| Summary: | summary |