The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Zimmer Persona Knee System.
Device ID | K113369 |
510k Number | K113369 |
Device Name: | ZIMMER PERSONA KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Kelli Anderson |
Correspondent | Kelli Anderson ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-15 |
Decision Date | 2012-03-27 |
Summary: | summary |