The following data is part of a premarket notification filed by Zimmer, Inc with the FDA for Persona Personalized Knee System.
| Device ID | K193223 |
| 510k Number | K193223 |
| 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 | 2019-11-22 |
| Decision Date | 2020-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024576223 | K193223 | 000 |
| 00889024576056 | K193223 | 000 |
| 00889024576049 | K193223 | 000 |
| 00889024575974 | K193223 | 000 |
| 00889024575967 | K193223 | 000 |
| 00889024575950 | K193223 | 000 |
| 00889024575943 | K193223 | 000 |
| 00889024575936 | K193223 | 000 |
| 00889024575929 | K193223 | 000 |
| 00889024575868 | K193223 | 000 |
| 00889024575851 | K193223 | 000 |
| 00889024575844 | K193223 | 000 |
| 00889024575837 | K193223 | 000 |
| 00889024575820 | K193223 | 000 |
| 00889024576063 | K193223 | 000 |
| 00889024576070 | K193223 | 000 |
| 00889024576216 | K193223 | 000 |
| 00889024576209 | K193223 | 000 |
| 00889024576193 | K193223 | 000 |
| 00889024576186 | K193223 | 000 |
| 00889024576179 | K193223 | 000 |
| 00889024576162 | K193223 | 000 |
| 00889024576155 | K193223 | 000 |
| 00889024576148 | K193223 | 000 |
| 00889024576124 | K193223 | 000 |
| 00889024576117 | K193223 | 000 |
| 00889024576100 | K193223 | 000 |
| 00889024576094 | K193223 | 000 |
| 00889024576087 | K193223 | 000 |
| 00889024575813 | K193223 | 000 |