The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5f/1.5t-3.5f/4.5t.
| Device ID | K093360 |
| 510k Number | K093360 |
| Device Name: | OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T |
| 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 | 2009-10-28 |
| Decision Date | 2010-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862255877 | K093360 | 000 |
| 10885862002693 | K093360 | 000 |
| 10885862002655 | K093360 | 000 |
| 10885862002648 | K093360 | 000 |
| 10885862002631 | K093360 | 000 |
| 10885862001276 | K093360 | 000 |
| 10885862001245 | K093360 | 000 |
| 10885862001139 | K093360 | 000 |
| 10885862175854 | K093360 | 000 |
| 10885862002709 | K093360 | 000 |
| 10885862002716 | K093360 | 000 |
| 10885862003133 | K093360 | 000 |
| 10885862255860 | K093360 | 000 |
| 10885862255853 | K093360 | 000 |
| 10885862175847 | K093360 | 000 |
| 10885862003218 | K093360 | 000 |
| 10885862003201 | K093360 | 000 |
| 10885862003195 | K093360 | 000 |
| 10885862003157 | K093360 | 000 |
| 10885862003140 | K093360 | 000 |
| 10885862001184 | K093360 | 000 |