The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Wagner Sl Revision Stem Lateral, Wagner Cone Prosthesis® System.
| Device ID | K161192 |
| 510k Number | K161192 |
| Device Name: | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System |
| 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 | Anne-kathrin Born ZIMMER GMBH SULZERALLEE 8 Winterthur, CH 8404 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024277748 | K161192 | 000 |
| 00889024277649 | K161192 | 000 |
| 00889024277656 | K161192 | 000 |
| 00889024277663 | K161192 | 000 |
| 00889024277670 | K161192 | 000 |
| 00889024277687 | K161192 | 000 |
| 00889024277694 | K161192 | 000 |
| 00889024277700 | K161192 | 000 |
| 00889024277717 | K161192 | 000 |
| 00889024277724 | K161192 | 000 |
| 00889024277731 | K161192 | 000 |
| 00889024277632 | K161192 | 000 |