The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Ecactech Porous Coated Finned Tibial Tray Compnent.
| Device ID | K936079 |
| 510k Number | K936079 |
| Device Name: | ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Tim Seese |
| Correspondent | Tim Seese 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 | 1993-12-22 |
| Decision Date | 1994-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862044372 | K936079 | 000 |
| 10885862046765 | K936079 | 000 |
| 10885862046772 | K936079 | 000 |
| 10885862046789 | K936079 | 000 |
| 10885862046796 | K936079 | 000 |
| 10885862046802 | K936079 | 000 |
| 10885862046819 | K936079 | 000 |
| 10885862046826 | K936079 | 000 |
| 10885862046833 | K936079 | 000 |
| 10885862046840 | K936079 | 000 |
| 10885862046857 | K936079 | 000 |
| 10885862046864 | K936079 | 000 |
| 10885862046871 | K936079 | 000 |
| 10885862046888 | K936079 | 000 |
| 10885862046758 | K936079 | 000 |