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 |