The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Hip Joint Replacement.
| Device ID | K200112 |
| 510k Number | K200112 |
| Device Name: | Zimmer Hip Joint Replacement |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Zimmer GmbH Sulzer Allee 6 Winterthur, CH 8404 |
| Contact | Thomas Lincoln |
| Correspondent | Anne-kathrin Born Zimmer GmbH Sulzer Allee 6 Winterthur, CH 8404 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-17 |
| Decision Date | 2020-04-10 |