The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Alloclassic Zweymuller Sl Femoral Stem, Alloclassic Zweymuller Sl Offset Femoral Stem.
| Device ID | K193050 |
| 510k Number | K193050 |
| Device Name: | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Contact | Roberto Tommasini |
| Correspondent | Gaelle Georges Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2019-12-26 |
| Summary: | summary |