The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Knee Joint Replacement Prostheses Mr Labeling.
| Device ID | K173057 |
| 510k Number | K173057 |
| Device Name: | Zimmer Knee Joint Replacement Prostheses MR Labeling |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Jason Heckaman |
| Correspondent | Jason Heckaman Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KRR |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-03-29 |
| Summary: | summary |