The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Persona Revision Knee System.
| Device ID | K210551 |
| 510k Number | K210551 |
| Device Name: | Persona Revision Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Contact | Romil Sheth |
| Correspondent | Romil Sheth Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2021-03-18 |