The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Logic Cr Tibial Insert, Optetrak Logic Cr Femoral Component.
| Device ID | K111400 |
| 510k Number | K111400 |
| Device Name: | OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT |
| 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 | 2011-05-19 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862158147 | K111400 | 000 |
| 10885862157973 | K111400 | 000 |
| 10885862157980 | K111400 | 000 |
| 10885862157997 | K111400 | 000 |
| 10885862158000 | K111400 | 000 |
| 10885862158017 | K111400 | 000 |
| 10885862158024 | K111400 | 000 |
| 10885862158031 | K111400 | 000 |
| 10885862158048 | K111400 | 000 |
| 10885862158079 | K111400 | 000 |
| 10885862158086 | K111400 | 000 |
| 10885862158093 | K111400 | 000 |
| 10885862158109 | K111400 | 000 |
| 10885862158116 | K111400 | 000 |
| 10885862158123 | K111400 | 000 |
| 10885862158130 | K111400 | 000 |
| 10885862186911 | K111400 | 000 |