The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Opteon Unipolar.
| Device ID | K960538 |
| 510k Number | K960538 |
| Device Name: | OPTEON UNIPOLAR |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-07 |
| Decision Date | 1996-03-27 |
| Summary: | summary |