The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Total Knee System Offset Tibial Tray.
| Device ID | K023186 |
| 510k Number | K023186 |
| Device Name: | OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Martin Sprunch |
| Correspondent | Martin Sprunch 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 | 2002-09-24 |
| Decision Date | 2002-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862056696 | K023186 | 000 |
| 10885862054807 | K023186 | 000 |
| 10885862054814 | K023186 | 000 |
| 10885862054821 | K023186 | 000 |
| 10885862054838 | K023186 | 000 |
| 10885862054845 | K023186 | 000 |
| 10885862054852 | K023186 | 000 |
| 10885862054869 | K023186 | 000 |
| 10885862054876 | K023186 | 000 |
| 10885862054791 | K023186 | 000 |
| 10885862054784 | K023186 | 000 |
| 10885862044426 | K023186 | 000 |
| 10885862054715 | K023186 | 000 |
| 10885862054722 | K023186 | 000 |
| 10885862054739 | K023186 | 000 |
| 10885862054746 | K023186 | 000 |
| 10885862054753 | K023186 | 000 |
| 10885862054760 | K023186 | 000 |
| 10885862054777 | K023186 | 000 |
| 10885862053411 | K023186 | 000 |
| 10885862053428 | K023186 | 000 |
| 10885862053251 | K023186 | 000 |
| 10885862053367 | K023186 | 000 |
| 10885862053374 | K023186 | 000 |
| 10885862053381 | K023186 | 000 |
| 10885862053398 | K023186 | 000 |
| 10885862053404 | K023186 | 000 |
| 10885862053435 | K023186 | 000 |
| 10885862053442 | K023186 | 000 |
| 10885862053459 | K023186 | 000 |
| 10885862053350 | K023186 | 000 |
| 10885862053343 | K023186 | 000 |
| 10885862053268 | K023186 | 000 |
| 10885862053275 | K023186 | 000 |
| 10885862053282 | K023186 | 000 |
| 10885862053299 | K023186 | 000 |
| 10885862053305 | K023186 | 000 |
| 10885862053312 | K023186 | 000 |
| 10885862053329 | K023186 | 000 |
| 10885862053336 | K023186 | 000 |
| 10885862053466 | K023186 | 000 |