The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Miller/galante Precoat Unicompartmental Knee.
| Device ID | K880155 |
| 510k Number | K880155 |
| Device Name: | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024192614 | K880155 | 000 |
| 00889024192447 | K880155 | 000 |
| 00889024192454 | K880155 | 000 |
| 00889024192478 | K880155 | 000 |
| 00889024192485 | K880155 | 000 |
| 00889024192492 | K880155 | 000 |
| 00889024192515 | K880155 | 000 |
| 00889024192522 | K880155 | 000 |
| 00889024192539 | K880155 | 000 |
| 00889024192553 | K880155 | 000 |
| 00889024192560 | K880155 | 000 |
| 00889024192577 | K880155 | 000 |
| 00889024192591 | K880155 | 000 |
| 00889024192607 | K880155 | 000 |
| 00889024192430 | K880155 | 000 |