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Exactech, Inc. FDA Approvals
0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Equinoxe® Shoulder System510(k)Apr 14, 2026Orthopedic |
| Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants510(k)Dec 1, 2025Orthopedic |
| Equinoxe® Shoulder System510(k)Aug 1, 2025Orthopedic |
| Equinoxe® Scapula Fracture System510(k)Jun 26, 2025Orthopedic |
| Alteon® HA Femoral Stems510(k)Mar 10, 2025Orthopedic |
| Exactech® TRULIANT® Knee System510(k)Oct 3, 2024Orthopedic |
| Equinoxe® Central Screw Baseplate System510(k)Jul 18, 2024Orthopedic |
| Exactech® Vantage® Total Ankle System510(k)Oct 12, 2023Orthopedic |
| Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws510(k)Sep 25, 2023Orthopedic |
| Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays510(k)Sep 14, 2023Orthopedic |
| Vantage® Total Ankle System510(k)Sep 11, 2023Orthopedic |
| TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas510(k)Jul 17, 2023Orthopedic |
| Exactech® Alteon® Short Tapered Wedge510(k)May 19, 2023Orthopedic |
| Exactech® Equinoxe® Laser Cage Glenoid510(k)Mar 4, 2022Orthopedic |