The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak 9mm Cruciate Retaining Tibial Insert, Slope ++.
| Device ID | K082022 |
| 510k Number | K082022 |
| Device Name: | OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham Cuthbert |
| Correspondent | Graham Cuthbert 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 | 2008-07-16 |
| Decision Date | 2008-09-02 |
| Summary: | summary |