The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Avenir Complete Hip System, Size 0 Coxa Vara.
| Device ID | K192189 |
| 510k Number | K192189 |
| Device Name: | Avenir Complete Hip System, Size 0 Coxa Vara |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Rebecca D Noftz |
| Correspondent | Neha Sreenath Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| 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 | 2019-08-13 |
| Decision Date | 2019-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024509252 | K192189 | 000 |
| 00889024508866 | K192189 | 000 |