The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trilogy Acetabular Shell & Liners 36mm.
| Device ID | K953490 |
| 510k Number | K953490 |
| Device Name: | TRILOGY ACETABULAR SHELL & LINERS 36MM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Theodore M Wendt |
| Correspondent | Theodore M Wendt 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 | 1995-07-25 |
| Decision Date | 1995-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024117914 | K953490 | 000 |