The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trilogy Acetabular System Constrained Liner, Model 6154 Series.
| Device ID | K021826 |
| 510k Number | K021826 |
| Device Name: | TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| 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 | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024570108 | K021826 | 000 |
| 00889024117426 | K021826 | 000 |
| 00889024117419 | K021826 | 000 |
| 00889024117402 | K021826 | 000 |
| 00889024117396 | K021826 | 000 |
| 00889024117389 | K021826 | 000 |
| 00889024117372 | K021826 | 000 |
| 00889024117365 | K021826 | 000 |
| 00889024117358 | K021826 | 000 |
| 00889024117341 | K021826 | 000 |
| 00889024117334 | K021826 | 000 |
| 00889024117327 | K021826 | 000 |
| 00889024117310 | K021826 | 000 |
| 00889024117433 | K021826 | 000 |
| 00889024569973 | K021826 | 000 |
| 00889024570092 | K021826 | 000 |
| 00889024570085 | K021826 | 000 |
| 00889024570078 | K021826 | 000 |
| 00889024570061 | K021826 | 000 |
| 00889024570054 | K021826 | 000 |
| 00889024570047 | K021826 | 000 |
| 00889024570030 | K021826 | 000 |
| 00889024570023 | K021826 | 000 |
| 00889024570016 | K021826 | 000 |
| 00889024570009 | K021826 | 000 |
| 00889024569997 | K021826 | 000 |
| 00889024569980 | K021826 | 000 |
| 00889024117303 | K021826 | 000 |