The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Optetrak Logic Enhanced Assembly.
| Device ID | K152170 |
| 510k Number | K152170 |
| Device Name: | Exactech Optetrak Logic Enhanced Assembly |
| 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 | 2015-08-04 |
| Decision Date | 2015-09-03 |
| Summary: | summary |