The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis With Kinectiv Technology System.
| Device ID | K081007 |
| 510k Number | K081007 |
| Device Name: | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Benjamin C Curson |
| Correspondent | Benjamin C Curson ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWA |
| Subsequent Product Code | JDL |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-08 |
| Decision Date | 2008-05-06 |
| Summary: | summary |