The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Persona Personalized Knee System.
Device ID | K150090 |
510k Number | K150090 |
Device Name: | Zimmer Persona 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 | Keith Proctor |
Correspondent | Andrea Pilon Artman 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 | 2015-01-16 |
Decision Date | 2015-05-20 |
Summary: | summary |