The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Persona Revision Knee System.
Device ID | K181947 |
510k Number | K181947 |
Device Name: | Persona Revision Knee System |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
Contact | Nicole Meredith |
Correspondent | Nicole Meredith 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 | 2018-07-20 |
Decision Date | 2018-10-25 |
Summary: | summary |