The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Persona Personalized Knee System.
Device ID | K221479 |
510k Number | K221479 |
Device Name: | Persona Personalized Knee System |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
Contact | Gregory Foster |
Correspondent | Gregory Foster Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
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 | 2022-05-23 |
Decision Date | 2022-11-17 |