The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trabecular Metal Primary Hip Prosthesis.
| Device ID | K051491 |
| 510k Number | K051491 |
| Device Name: | TRABECULAR METAL PRIMARY HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-06 |
| Decision Date | 2005-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024139367 | K051491 | 000 |
| 00889024139251 | K051491 | 000 |
| 00889024139244 | K051491 | 000 |
| 00889024139237 | K051491 | 000 |
| 00889024139220 | K051491 | 000 |
| 00889024139213 | K051491 | 000 |
| 00889024139206 | K051491 | 000 |
| 00889024139190 | K051491 | 000 |
| 00889024362215 | K051491 | 000 |
| 00889024139268 | K051491 | 000 |
| 00889024139275 | K051491 | 000 |
| 00889024139350 | K051491 | 000 |
| 00889024139343 | K051491 | 000 |
| 00889024139336 | K051491 | 000 |
| 00889024139329 | K051491 | 000 |
| 00889024139312 | K051491 | 000 |
| 00889024139305 | K051491 | 000 |
| 00889024139299 | K051491 | 000 |
| 00889024139282 | K051491 | 000 |
| 00889024362208 | K051491 | 000 |