The following data is part of a premarket notification filed by Exactech Sarasota with the FDA for Optertrak Logic Psc Tibial Insert.
| Device ID | K110547 |
| 510k Number | K110547 |
| Device Name: | OPTERTRAK LOGIC PSC TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH SARASOTA 2320 NW 66TH COURT Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH SARASOTA 2320 NW 66TH COURT 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 | 2011-02-25 |
| Decision Date | 2011-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862310453 | K110547 | 000 |
| 10885862310446 | K110547 | 000 |
| 10885862310439 | K110547 | 000 |