The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Avenir Muller Stem.
| Device ID | K123392 |
| 510k Number | K123392 |
| Device Name: | AVENIR MULLER 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 | 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 | 2012-11-02 |
| Decision Date | 2013-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024481268 | K123392 | 000 |
| 00889024288164 | K123392 | 000 |
| 00889024288157 | K123392 | 000 |
| 00889024288140 | K123392 | 000 |
| 00889024288133 | K123392 | 000 |
| 00889024288126 | K123392 | 000 |
| 00889024288119 | K123392 | 000 |
| 00889024288102 | K123392 | 000 |
| 00889024288096 | K123392 | 000 |
| 00889024288089 | K123392 | 000 |
| 00889024288072 | K123392 | 000 |
| 00889024288065 | K123392 | 000 |
| 00889024288058 | K123392 | 000 |
| 00889024288171 | K123392 | 000 |
| 00889024288188 | K123392 | 000 |
| 00889024288195 | K123392 | 000 |
| 00889024479586 | K123392 | 000 |
| 00889024479562 | K123392 | 000 |
| 00889024479555 | K123392 | 000 |
| 00889024479531 | K123392 | 000 |
| 00889024479517 | K123392 | 000 |
| 00889024479500 | K123392 | 000 |
| 00889024479494 | K123392 | 000 |
| 00889024479463 | K123392 | 000 |
| 00889024479432 | K123392 | 000 |
| 00889024512405 | K123392 | 000 |
| 00889024288218 | K123392 | 000 |
| 00889024288201 | K123392 | 000 |
| 00889024288041 | K123392 | 000 |