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 |