The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis.
| Device ID | K061786 |
| 510k Number | K061786 |
| Device Name: | VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Jenks |
| Correspondent | Patricia Jenks 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 | 2006-06-26 |
| Decision Date | 2006-07-24 |
| Summary: | summary |