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, Model(s) 7848 Series( Modular Necks), 7713 Series.
| Device ID | K071856 |
| 510k Number | K071856 |
| Device Name: | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| 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 | KWA |
| Subsequent Product Code | JDL |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024138056 | K071856 | 000 |
| 00889024509535 | K071856 | 000 |
| 00889024509542 | K071856 | 000 |
| 00889024509559 | K071856 | 000 |
| 00889024509566 | K071856 | 000 |
| 00889024509573 | K071856 | 000 |
| 00889024509580 | K071856 | 000 |
| 00889024509597 | K071856 | 000 |
| 00889024509603 | K071856 | 000 |
| 00889024509528 | K071856 | 000 |
| 00889024509511 | K071856 | 000 |
| 00889024509436 | K071856 | 000 |
| 00889024509443 | K071856 | 000 |
| 00889024509450 | K071856 | 000 |
| 00889024509467 | K071856 | 000 |
| 00889024509474 | K071856 | 000 |
| 00889024509481 | K071856 | 000 |
| 00889024509498 | K071856 | 000 |
| 00889024509504 | K071856 | 000 |
| 00889024509610 | K071856 | 000 |
| 00889024137752 | K071856 | 000 |
| 00889024137943 | K071856 | 000 |
| 00889024137950 | K071856 | 000 |
| 00889024137967 | K071856 | 000 |
| 00889024137981 | K071856 | 000 |
| 00889024138001 | K071856 | 000 |
| 00889024138018 | K071856 | 000 |
| 00889024138025 | K071856 | 000 |
| 00889024138032 | K071856 | 000 |
| 00889024137936 | K071856 | 000 |
| 00889024137912 | K071856 | 000 |
| 00889024137776 | K071856 | 000 |
| 00889024137790 | K071856 | 000 |
| 00889024137813 | K071856 | 000 |
| 00889024137837 | K071856 | 000 |
| 00889024137851 | K071856 | 000 |
| 00889024137868 | K071856 | 000 |
| 00889024137875 | K071856 | 000 |
| 00889024137899 | K071856 | 000 |
| 00889024509429 | K071856 | 000 |