The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing And Tivanium Ti-6al-4v Alloy Femoral.
| Device ID | K062768 |
| 510k Number | K062768 |
| Device Name: | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Anthony Francalancia |
| Correspondent | Anthony Francalancia ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2006-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024213531 | K062768 | 000 |
| 00889024213524 | K062768 | 000 |
| 00889024213548 | K062768 | 000 |
| 00889024213555 | K062768 | 000 |
| 00889024213562 | K062768 | 000 |
| 00889024213579 | K062768 | 000 |
| 00889024213586 | K062768 | 000 |
| 00889024213593 | K062768 | 000 |
| 00889024213609 | K062768 | 000 |
| 00889024213517 | K062768 | 000 |