The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Fitmore Hip Stem.
| Device ID | K192236 |
| 510k Number | K192236 |
| Device Name: | Fitmore Hip Stem |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Zimmer GmbH Sulzer Allee 8 Winterthur, CH 8404 |
| Contact | Roberto Tommasini |
| Correspondent | Tobias Moller Zimmer GmbH Sulzer Allee 8 Winterthur, CH 8404 |
| Product Code | KWY |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2019-11-05 |