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 |