The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optetrak Constrained Condylar Knee For Cemented Use Only.
| Device ID | K954208 |
| 510k Number | K954208 |
| Device Name: | OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-07 |
| Decision Date | 1996-02-26 |