The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Avenir Cemented Hip Stem.
| Device ID | K131884 |
| 510k Number | K131884 |
| Device Name: | AVENIR CEMENTED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Karen O'leary |
| Correspondent | Karen O'leary ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024288393 | K131884 | 000 |
| 00889024288232 | K131884 | 000 |
| 00889024288249 | K131884 | 000 |
| 00889024288256 | K131884 | 000 |
| 00889024288263 | K131884 | 000 |
| 00889024288270 | K131884 | 000 |
| 00889024288287 | K131884 | 000 |
| 00889024288294 | K131884 | 000 |
| 00889024288300 | K131884 | 000 |
| 00889024288317 | K131884 | 000 |
| 00889024288324 | K131884 | 000 |
| 00889024288331 | K131884 | 000 |
| 00889024288348 | K131884 | 000 |
| 00889024288355 | K131884 | 000 |
| 00889024288362 | K131884 | 000 |
| 00889024288379 | K131884 | 000 |
| 00889024288386 | K131884 | 000 |
| 00889024288225 | K131884 | 000 |