The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Logic Combination Tibial Tray.
| Device ID | K101981 |
| 510k Number | K101981 |
| Device Name: | OPTETRAK LOGIC COMBINATION TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-14 |
| Decision Date | 2010-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862169600 | K101981 | 000 |
| 10885862003850 | K101981 | 000 |
| 10885862003843 | K101981 | 000 |
| 10885862004024 | K101981 | 000 |
| 10885862003997 | K101981 | 000 |
| 10885862003980 | K101981 | 000 |
| 10885862003973 | K101981 | 000 |
| 10885862003966 | K101981 | 000 |
| 10885862275073 | K101981 | 000 |
| 10885862219855 | K101981 | 000 |
| 10885862157584 | K101981 | 000 |
| 10885862157515 | K101981 | 000 |
| 10885862157508 | K101981 | 000 |
| 10885862157492 | K101981 | 000 |
| 10885862157577 | K101981 | 000 |
| 10885862157485 | K101981 | 000 |
| 10885862157478 | K101981 | 000 |
| 10885862157461 | K101981 | 000 |
| 10885862003867 | K101981 | 000 |
| 10885862003874 | K101981 | 000 |
| 10885862003881 | K101981 | 000 |
| 10885862169280 | K101981 | 000 |
| 10885862167330 | K101981 | 000 |
| 10885862004086 | K101981 | 000 |
| 10885862004079 | K101981 | 000 |
| 10885862004062 | K101981 | 000 |
| 10885862004055 | K101981 | 000 |
| 10885862004048 | K101981 | 000 |
| 10885862004031 | K101981 | 000 |
| 10885862004017 | K101981 | 000 |
| 10885862004000 | K101981 | 000 |
| 10885862003959 | K101981 | 000 |
| 10885862003942 | K101981 | 000 |
| 10885862003935 | K101981 | 000 |
| 10885862003928 | K101981 | 000 |
| 10885862003911 | K101981 | 000 |
| 10885862003904 | K101981 | 000 |
| 10885862003898 | K101981 | 000 |
| 10885862157454 | K101981 | 000 |