The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Triology Acetabular System 46mm Large Head Liners, Model 6310.
| Device ID | K003478 |
| 510k Number | K003478 |
| Device Name: | TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 |
| 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 | 2000-11-09 |
| Decision Date | 2001-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024124530 | K003478 | 000 |
| 00889024123939 | K003478 | 000 |
| 00889024123991 | K003478 | 000 |
| 00889024124059 | K003478 | 000 |
| 00889024124110 | K003478 | 000 |
| 00889024124172 | K003478 | 000 |
| 00889024124233 | K003478 | 000 |
| 00889024124295 | K003478 | 000 |
| 00889024124356 | K003478 | 000 |
| 00889024124417 | K003478 | 000 |
| 00889024124479 | K003478 | 000 |
| 00889024123878 | K003478 | 000 |