The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis.
| Device ID | K060040 |
| 510k Number | K060040 |
| Device Name: | ZIMMER M/L TAPER HIP PROSTHESIS |
| 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 |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024172791 | K060040 | 000 |
| 00889024172784 | K060040 | 000 |
| 00889024131651 | K060040 | 000 |
| 00889024131637 | K060040 | 000 |
| 00889024131613 | K060040 | 000 |
| 00889024131606 | K060040 | 000 |
| 00889024366350 | K060040 | 000 |
| 00889024366343 | K060040 | 000 |
| 00889024132030 | K060040 | 000 |