The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Zimmer Persona Tm Personalized Knee System.
Device ID | K123459 |
510k Number | K123459 |
Device Name: | ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Carol Vierling, Rac |
Correspondent | Carol Vierling, Rac ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | MBH |
Subsequent Product Code | JWH |
Subsequent Product Code | OIY |
CFR Regulation Number | 888.3565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-09 |
Decision Date | 2013-02-22 |
Summary: | summary |