Exactech, Inc. - FDA 510(k) Cleared Devices
186
Total
174
Cleared
0
Denied
Exactech, Inc. has 174 FDA 510(k) cleared orthopedic devices. Based in Gainesville, US.
Latest FDA clearance: Apr 2026. Active since 1986.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Advita Ortho as regulatory consultant.
186 devices
Cleared
Apr 14, 2026
Equinoxe® Shoulder System
Orthopedic
53d
Cleared
Dec 01, 2025
Equinoxe® Humeral Reconstruction Prosthesis
Orthopedic
266d
Cleared
Aug 01, 2025
Equinoxe® Shoulder System
Orthopedic
267d
Cleared
Jun 26, 2025
Equinoxe® Scapula Fracture System
Orthopedic
253d
Cleared
Mar 10, 2025
Alteon® HA Femoral Stems
Orthopedic
87d
Cleared
Oct 03, 2024
Exactech® TRULIANT® Knee System
Orthopedic
238d
Cleared
Jul 18, 2024
Equinoxe® Central Screw Baseplate System
Orthopedic
266d
Cleared
Oct 12, 2023
Exactech® Vantage® Total Ankle System
Orthopedic
211d
Cleared
Sep 25, 2023
Exactech Equinoxe PHx Fracture System
Orthopedic
269d
Cleared
Sep 14, 2023
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Orthopedic
266d
Cleared
Sep 11, 2023
Vantage® Total Ankle System
Orthopedic
68d
Cleared
Jul 17, 2023
TRULIANT® E-PX Tibial Inserts
Orthopedic
269d
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