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 |