The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trabecular Metal Acetabular Revision System Cage.
| Device ID | K061226 |
| 510k Number | K061226 |
| Device Name: | TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Jenks |
| Correspondent | Patricia Jenks ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024130661 | K061226 | 000 |
| 00889024130555 | K061226 | 000 |
| 00889024130548 | K061226 | 000 |
| 00889024130531 | K061226 | 000 |
| 00889024130524 | K061226 | 000 |
| 00889024130517 | K061226 | 000 |
| 00889024130500 | K061226 | 000 |
| 00889024130494 | K061226 | 000 |
| 00889024130487 | K061226 | 000 |
| 00889024130562 | K061226 | 000 |
| 00889024130579 | K061226 | 000 |
| 00889024130654 | K061226 | 000 |
| 00889024130647 | K061226 | 000 |
| 00889024130630 | K061226 | 000 |
| 00889024130623 | K061226 | 000 |
| 00889024130616 | K061226 | 000 |
| 00889024130609 | K061226 | 000 |
| 00889024130593 | K061226 | 000 |
| 00889024130586 | K061226 | 000 |
| 00889024130470 | K061226 | 000 |