The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/constrained Condylar Knee Femoral Components/articular Surfaces.
| Device ID | K960279 |
| 510k Number | K960279 |
| Device Name: | NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Ruth Ann Wood |
| Correspondent | Ruth Ann Wood ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-19 |
| Decision Date | 1996-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024221598 | K960279 | 000 |
| 00889024472914 | K960279 | 000 |
| 00889024472907 | K960279 | 000 |
| 00889024472891 | K960279 | 000 |
| 00889024472884 | K960279 | 000 |
| 00889024472877 | K960279 | 000 |
| 00889024225459 | K960279 | 000 |
| 00889024225398 | K960279 | 000 |
| 00889024225381 | K960279 | 000 |
| 00889024472921 | K960279 | 000 |
| 00889024472938 | K960279 | 000 |
| 00889024473010 | K960279 | 000 |
| 00889024473003 | K960279 | 000 |
| 00889024472990 | K960279 | 000 |
| 00889024472983 | K960279 | 000 |
| 00889024472976 | K960279 | 000 |
| 00889024472969 | K960279 | 000 |
| 00889024472952 | K960279 | 000 |
| 00889024472945 | K960279 | 000 |
| 00889024225312 | K960279 | 000 |