The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution.
| Device ID | K963148 |
| 510k Number | K963148 |
| Device Name: | NEXGEN COMPLETE KNEE SOLUTION |
| 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 | 1996-08-13 |
| Decision Date | 1997-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024228108 | K963148 | 000 |
| 00889024228092 | K963148 | 000 |
| 00889024228085 | K963148 | 000 |
| 00889024228078 | K963148 | 000 |
| 00889024228061 | K963148 | 000 |
| 00889024228054 | K963148 | 000 |
| 00889024228047 | K963148 | 000 |
| 00889024228030 | K963148 | 000 |