The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trilogy Acetabular System Large Head Liner, Model 6353.
| Device ID | K002960 |
| 510k Number | K002960 |
| Device Name: | TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Karen Cain |
| Correspondent | Karen Cain 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 | 2000-09-22 |
| Decision Date | 2000-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024125360 | K002960 | 000 |
| 00889024124400 | K002960 | 000 |
| 00889024124349 | K002960 | 000 |
| 00889024124288 | K002960 | 000 |
| 00889024124226 | K002960 | 000 |
| 00889024124165 | K002960 | 000 |
| 00889024124103 | K002960 | 000 |
| 00889024124042 | K002960 | 000 |
| 00889024123984 | K002960 | 000 |
| 00889024123922 | K002960 | 000 |
| 00889024123861 | K002960 | 000 |
| 00889024123816 | K002960 | 000 |
| 00889024124462 | K002960 | 000 |
| 00889024124523 | K002960 | 000 |
| 00889024125315 | K002960 | 000 |
| 00889024125261 | K002960 | 000 |
| 00889024125216 | K002960 | 000 |
| 00889024125162 | K002960 | 000 |
| 00889024125117 | K002960 | 000 |
| 00889024125063 | K002960 | 000 |
| 00889024125018 | K002960 | 000 |
| 00889024124967 | K002960 | 000 |
| 00889024124912 | K002960 | 000 |
| 00889024124868 | K002960 | 000 |
| 00889024124813 | K002960 | 000 |
| 00889024123762 | K002960 | 000 |