The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Miller/galante Precoat Unicompartmental Knee System.
| Device ID | K942263 |
| 510k Number | K942263 |
| Device Name: | MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Ruth A Wood |
| Correspondent | Ruth A Wood ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1995-07-11 |