The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versa-fx Femoral Fixation System.
| Device ID | K954555 |
| 510k Number | K954555 |
| Device Name: | VERSA-FX FEMORAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-01-26 |