The following data is part of a premarket notification filed by Exactech Inc with the FDA for Optetrak One Logic Femoral Components.
| Device ID | K153776 |
| 510k Number | K153776 |
| Device Name: | Optetrak One Logic Femoral Components |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-31 |
| Decision Date | 2016-03-10 |
| Summary: | summary |