The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Trumatch Personalized Solutions.
| Device ID | K193540 |
| 510k Number | K193540 |
| Device Name: | TRUMATCH Personalized Solutions |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582 |
| Contact | Erin Combs |
| Correspondent | Melissa Cook DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-06-16 |