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 |