The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis With Calcicoat Ceramic Coating.
| Device ID | K042337 |
| 510k Number | K042337 |
| Device Name: | ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dalene Binkley |
| Correspondent | Dalene Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024173057 | K042337 | 000 |
| 00889024172852 | K042337 | 000 |
| 00889024172845 | K042337 | 000 |
| 00889024172838 | K042337 | 000 |
| 00889024172821 | K042337 | 000 |
| 00889024172814 | K042337 | 000 |
| 00889024172807 | K042337 | 000 |
| 00889024173033 | K042337 | 000 |
| 00889024366473 | K042337 | 000 |
| 00889024366466 | K042337 | 000 |
| 00889024366459 | K042337 | 000 |
| 00889024366442 | K042337 | 000 |
| 00889024366435 | K042337 | 000 |
| 00889024366428 | K042337 | 000 |
| 00889024366411 | K042337 | 000 |
| 00889024366404 | K042337 | 000 |
| 00889024366398 | K042337 | 000 |
| 00889024172869 | K042337 | 000 |
| 00889024172876 | K042337 | 000 |
| 00889024173040 | K042337 | 000 |
| 00889024173026 | K042337 | 000 |
| 00889024173019 | K042337 | 000 |
| 00889024173002 | K042337 | 000 |
| 00889024172999 | K042337 | 000 |
| 00889024172982 | K042337 | 000 |
| 00889024172975 | K042337 | 000 |
| 00889024172968 | K042337 | 000 |
| 00889024172951 | K042337 | 000 |
| 00889024172944 | K042337 | 000 |
| 00889024172937 | K042337 | 000 |
| 00889024172920 | K042337 | 000 |
| 00889024172913 | K042337 | 000 |
| 00889024172906 | K042337 | 000 |
| 00889024172890 | K042337 | 000 |
| 00889024172883 | K042337 | 000 |
| 00889024366374 | K042337 | 000 |