The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Persona The Personalized Knee System.
Device ID | K121771 |
510k Number | K121771 |
Device Name: | ZIMMER PERSONA THE 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 | Kelli J Anderson |
Correspondent | Kelli J Anderson 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 | 2012-06-15 |
Decision Date | 2012-11-07 |
Summary: | summary |