The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Trumatch Personalized Solutions.
| Device ID | K110397 |
| 510k Number | K110397 |
| Device Name: | TRUMATCH PERSONALIZED SOLUTIONS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Nancy S Friddle |
| Correspondent | Nancy S Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-08-16 |
| Summary: | summary |