The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Cross-linked Polyethylene Cruciate Retaining (cr) Articular Surface Components.
| Device ID | K003910 |
| 510k Number | K003910 |
| Device Name: | NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey 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 | 2000-12-19 |
| Decision Date | 2001-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024445260 | K003910 | 000 |
| 00889024208001 | K003910 | 000 |
| 00889024208018 | K003910 | 000 |
| 00889024208032 | K003910 | 000 |
| 00889024208049 | K003910 | 000 |
| 00889024208056 | K003910 | 000 |
| 00889024208063 | K003910 | 000 |
| 00889024208070 | K003910 | 000 |
| 00889024208094 | K003910 | 000 |
| 00889024207981 | K003910 | 000 |
| 00889024207974 | K003910 | 000 |
| 00889024207967 | K003910 | 000 |
| 00889024445277 | K003910 | 000 |
| 00889024445284 | K003910 | 000 |
| 00889024445291 | K003910 | 000 |
| 00889024445307 | K003910 | 000 |
| 00889024429239 | K003910 | 000 |
| 00889024207929 | K003910 | 000 |
| 00889024207936 | K003910 | 000 |
| 00889024207943 | K003910 | 000 |
| 00889024208100 | K003910 | 000 |
| 00889024429147 | K003910 | 000 |
| 00889024429154 | K003910 | 000 |
| 00889024263437 | K003910 | 000 |
| 00889024207912 | K003910 | 000 |
| 00889024208087 | K003910 | 000 |
| 00889024263420 | K003910 | 000 |
| 00889024263444 | K003910 | 000 |
| 00889024263451 | K003910 | 000 |
| 00889024263468 | K003910 | 000 |
| 00889024263475 | K003910 | 000 |
| 00889024263413 | K003910 | 000 |
| 00889024208025 | K003910 | 000 |
| 00889024207998 | K003910 | 000 |
| 00889024429161 | K003910 | 000 |
| 00889024429178 | K003910 | 000 |
| 00889024429185 | K003910 | 000 |
| 00889024429192 | K003910 | 000 |
| 00889024429208 | K003910 | 000 |
| 00889024429215 | K003910 | 000 |
| 00889024429222 | K003910 | 000 |
| 00889024207950 | K003910 | 000 |
| 00889024263482 | K003910 | 000 |