The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Beaded Fullcoat Bowed Revision Hip Prosthesis.
| Device ID | K030079 |
| 510k Number | K030079 |
| Device Name: | VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Fred Mcclure |
| Correspondent | Fred Mcclure 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 | 2003-01-09 |
| Decision Date | 2003-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024137325 | K030079 | 000 |
| 00889024136878 | K030079 | 000 |
| 00889024136861 | K030079 | 000 |
| 00889024136816 | K030079 | 000 |
| 00889024136779 | K030079 | 000 |
| 00889024136762 | K030079 | 000 |
| 00889024136717 | K030079 | 000 |
| 00889024136618 | K030079 | 000 |
| 00889024136601 | K030079 | 000 |
| 00889024136564 | K030079 | 000 |
| 00889024136960 | K030079 | 000 |
| 00889024137011 | K030079 | 000 |
| 00889024137318 | K030079 | 000 |
| 00889024137264 | K030079 | 000 |
| 00889024137240 | K030079 | 000 |
| 00889024137233 | K030079 | 000 |
| 00889024137189 | K030079 | 000 |
| 00889024137103 | K030079 | 000 |
| 00889024137097 | K030079 | 000 |
| 00889024137042 | K030079 | 000 |
| 00889024137028 | K030079 | 000 |
| 00889024136496 | K030079 | 000 |