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Exactech, Inc.

FDA 510(k) & PMA Approved Devices — 41 products

Total Devices41
Categories14
Latest FDA decision2026-04-14
TypeNumberDevice NameCodeDateActions
510(k) K260583 Equinoxe® Shoulder SystemPHX2026-04-14 View
510(k) K250713 Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT2025-12-01 View
510(k) K243448 Equinoxe® Shoulder SystemPHX2025-08-01 View
510(k) K243275 Equinoxe® Scapula Fracture SystemHRS2025-06-26 View
510(k) K243839 Alteon® HA Femoral StemsMEH2025-03-10 View
510(k) K240393 Exactech® TRULIANT® Knee SystemMBH2024-10-03 View
510(k) K233482 Equinoxe® Central Screw Baseplate SystemPHX2024-07-18 View
510(k) K230717 Exactech® Vantage® Total Ankle SystemHSN2023-10-12 View
510(k) K223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS2023-09-25 View
510(k) K223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX2023-09-14 View
510(k) K232002 Vantage® Total Ankle SystemHSN2023-09-11 View
510(k) K223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasJWH2023-07-17 View
510(k) K221323 Exactech® Alteon® Short Tapered WedgeLZO2023-05-19 View
510(k) K212356 Exactech® Equinoxe® Laser Cage GlenoidKWS2022-03-04 View
510(k) K192097 Exactech® Equinoxe® Stemless Humeral ComponentsPKC2020-04-29 View
510(k) K193098 Exactech® Equinoxe® Reverse Shoulder GlenospheresPHX2020-02-20 View
510(k) K190890 Exactech Alteon Modular Dual Mobility (MDM) SystemLZO2019-10-22 View
510(k) K191561 Exactech Equinoxe Humeral Augmented TraysPHX2019-08-20 View
510(k) K183343 Vantage Total Ankle Flat Cut Talar ComponentsHSN2019-04-01 View
510(k) K182502 Alteon Acetabular Cup SystemLPH2019-03-13 View

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