The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Persona Personalized Knee System.
| Device ID | K200209 |
| 510k Number | K200209 |
| Device Name: | Persona Personalized Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Contact | Gregory Foster |
| Correspondent | Gregory Foster Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024576643 | K200209 | 000 |
| 00889024576476 | K200209 | 000 |
| 00889024576469 | K200209 | 000 |
| 00889024576391 | K200209 | 000 |
| 00889024576384 | K200209 | 000 |
| 00889024576377 | K200209 | 000 |
| 00889024576360 | K200209 | 000 |
| 00889024576353 | K200209 | 000 |
| 00889024576346 | K200209 | 000 |
| 00889024576285 | K200209 | 000 |
| 00889024576278 | K200209 | 000 |
| 00889024576261 | K200209 | 000 |
| 00889024576254 | K200209 | 000 |
| 00889024576247 | K200209 | 000 |
| 00889024576483 | K200209 | 000 |
| 00889024576490 | K200209 | 000 |
| 00889024576636 | K200209 | 000 |
| 00889024576629 | K200209 | 000 |
| 00889024576612 | K200209 | 000 |
| 00889024576605 | K200209 | 000 |
| 00889024576599 | K200209 | 000 |
| 00889024576582 | K200209 | 000 |
| 00889024576575 | K200209 | 000 |
| 00889024576568 | K200209 | 000 |
| 00889024576544 | K200209 | 000 |
| 00889024576537 | K200209 | 000 |
| 00889024576520 | K200209 | 000 |
| 00889024576513 | K200209 | 000 |
| 00889024576506 | K200209 | 000 |
| 00889024576230 | K200209 | 000 |