The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Persona Personalized Knee System.
| Device ID | K172524 |
| 510k Number | K172524 |
| 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 | Nicole Meredith |
| Correspondent | Nicole Meredith 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 | 2017-08-21 |
| Decision Date | 2018-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024583535 | K172524 | 000 |
| 00889024674011 | K172524 | 000 |
| 00889024674004 | K172524 | 000 |
| 00889024673991 | K172524 | 000 |
| 00889024673984 | K172524 | 000 |
| 00889024673977 | K172524 | 000 |
| 00889024673960 | K172524 | 000 |
| 00889024673953 | K172524 | 000 |
| 00889024673946 | K172524 | 000 |
| 00889024674028 | K172524 | 000 |
| 00889024583443 | K172524 | 000 |
| 00889024583528 | K172524 | 000 |
| 00889024583511 | K172524 | 000 |
| 00889024583504 | K172524 | 000 |
| 00889024583498 | K172524 | 000 |
| 00889024583481 | K172524 | 000 |
| 00889024583474 | K172524 | 000 |
| 00889024583467 | K172524 | 000 |
| 00889024583450 | K172524 | 000 |
| 00889024673939 | K172524 | 000 |