The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-xxx-xx.
| Device ID | K042776 |
| 510k Number | K042776 |
| Device Name: | VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Karen Cain |
| Correspondent | Karen Cain ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024136809 | K042776 | 000 |
| 00889024136700 | K042776 | 000 |
| 00889024136649 | K042776 | 000 |
| 00889024136557 | K042776 | 000 |
| 00889024136489 | K042776 | 000 |
| 00889024136427 | K042776 | 000 |