The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Logic Cr Tibial Insert, Size 0 Optetrak Logic Cr Tibial Insert, Size 6 Optetrak Logic Cr Femoral Component, Siz.
| Device ID | K121307 |
| 510k Number | K121307 |
| Device Name: | OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ |
| 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 | 2012-05-01 |
| Decision Date | 2012-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862158154 | K121307 | 000 |
| 10885862158062 | K121307 | 000 |
| 10885862158055 | K121307 | 000 |
| 10885862157966 | K121307 | 000 |