The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Optetrak Unicondylar Knee.
| Device ID | K040889 |
| 510k Number | K040889 |
| Device Name: | EXACTECH OPTETRAK UNICONDYLAR KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary Miller |
| Correspondent | Gary Miller EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2004-10-01 |
| Summary: | summary |