The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Persona Personalized Knee System.
Device ID | K142787 |
510k Number | K142787 |
Device Name: | Zimmer Persona Personalized Knee System |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Keith Proctor |
Correspondent | Dan Williman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | JWH |
Subsequent Product Code | MBH |
Subsequent Product Code | OIY |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-26 |
Decision Date | 2014-12-22 |
Summary: | summary |