The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Logic Porous Femoral Components.
| Device ID | K140302 |
| 510k Number | K140302 |
| Device Name: | OPTETRAK LOGIC POROUS FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-06 |
| Decision Date | 2014-07-30 |
| Summary: | summary |