The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trilogy Longevity Constrained Liner.
| Device ID | K071718 |
| 510k Number | K071718 |
| Device Name: | TRILOGY LONGEVITY CONSTRAINED LINER |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey 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 | 2007-06-22 |
| Decision Date | 2007-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024126213 | K071718 | 000 |
| 00889024126091 | K071718 | 000 |
| 00889024126107 | K071718 | 000 |
| 00889024126114 | K071718 | 000 |
| 00889024126121 | K071718 | 000 |
| 00889024126138 | K071718 | 000 |
| 00889024126145 | K071718 | 000 |
| 00889024126152 | K071718 | 000 |
| 00889024126169 | K071718 | 000 |
| 00889024126176 | K071718 | 000 |
| 00889024126183 | K071718 | 000 |
| 00889024126190 | K071718 | 000 |
| 00889024126206 | K071718 | 000 |
| 00889024126084 | K071718 | 000 |