The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Beaded Fullcoat Calcar Hip Prosthesis.
| Device ID | K033034 |
| 510k Number | K033034 |
| Device Name: | VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS |
| 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 | 2003-09-29 |
| Decision Date | 2003-11-05 |
| Summary: | summary |