The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trabecular Metal Acetabular Revision System Cemented Contrained Liner.
| Device ID | K072121 |
| 510k Number | K072121 |
| Device Name: | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| 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 | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-01 |
| Decision Date | 2008-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024130333 | K072121 | 000 |
| 00889024670174 | K072121 | 000 |
| 00889024670167 | K072121 | 000 |
| 00889024670150 | K072121 | 000 |
| 00889024670143 | K072121 | 000 |
| 00889024670136 | K072121 | 000 |
| 00889024670129 | K072121 | 000 |
| 00889024670112 | K072121 | 000 |
| 00889024670105 | K072121 | 000 |
| 00889024670181 | K072121 | 000 |
| 00889024130241 | K072121 | 000 |
| 00889024130326 | K072121 | 000 |
| 00889024130319 | K072121 | 000 |
| 00889024130302 | K072121 | 000 |
| 00889024130296 | K072121 | 000 |
| 00889024130289 | K072121 | 000 |
| 00889024130272 | K072121 | 000 |
| 00889024130265 | K072121 | 000 |
| 00889024130258 | K072121 | 000 |
| 00889024670099 | K072121 | 000 |