The following data is part of a premarket notification filed by Exactech Inc with the FDA for Truliant Femoral Components.
| Device ID | K170240 |
| 510k Number | K170240 |
| Device Name: | Truliant Femoral Components |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Exactech Inc 2320 NW 66th CT Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes Exactech Inc 2320 NW 66th CT Gainesville, FL 32653 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-26 |
| Decision Date | 2017-02-23 |
| Summary: | summary |