The following data is part of a premarket notification filed by Exactech Inc with the FDA for Optetrak Logic Metaphyseal Cones.
| Device ID | K153595 |
| 510k Number | K153595 |
| Device Name: | Optetrak Logic Metaphyseal Cones |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH INC 2320 NW 66TH COURT Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH INC 2320 NW 66TH COURT Gainesville, FL 32653 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862313768 | K153595 | 000 |
| 10885862313539 | K153595 | 000 |
| 10885862313522 | K153595 | 000 |
| 10885862313515 | K153595 | 000 |
| 10885862313508 | K153595 | 000 |
| 10885862313492 | K153595 | 000 |
| 10885862313485 | K153595 | 000 |
| 10885862313478 | K153595 | 000 |
| 10885862313461 | K153595 | 000 |
| 10885862302564 | K153595 | 000 |
| 10885862313775 | K153595 | 000 |
| 10885862313782 | K153595 | 000 |
| 10885862313751 | K153595 | 000 |
| 10885862313744 | K153595 | 000 |
| 10885862313737 | K153595 | 000 |
| 10885862313720 | K153595 | 000 |
| 10885862515285 | K153595 | 000 |
| 10885862515278 | K153595 | 000 |
| 10885862515261 | K153595 | 000 |
| 10885862515254 | K153595 | 000 |
| 10885862515247 | K153595 | 000 |
| 10885862302557 | K153595 | 000 |