The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Millar/galante Precoated Total Knee.
Device ID | K853661 |
510k Number | K853661 |
Device Name: | MILLAR/GALANTE PRECOATED TOTAL KNEE |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Max Sherman |
Correspondent | Max Sherman 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 | 1985-09-03 |
Decision Date | 1985-12-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887868347474 | K853661 | 000 |