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Exactech, Inc.

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

Total Devices41
Categories14
Latest Approval2026-04-14
TypeNumberDevice NameCodeDate
510(k) K260583 Equinoxe® Shoulder System PHX 2026-04-14 View
510(k) K250713 Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants KWT 2025-12-01 View
510(k) K243448 Equinoxe® Shoulder System PHX 2025-08-01 View
510(k) K243275 Equinoxe® Scapula Fracture System HRS 2025-06-26 View
510(k) K243839 Alteon® HA Femoral Stems MEH 2025-03-10 View
510(k) K240393 Exactech® TRULIANT® Knee System MBH 2024-10-03 View
510(k) K233482 Equinoxe® Central Screw Baseplate System PHX 2024-07-18 View
510(k) K230717 Exactech® Vantage® Total Ankle System HSN 2023-10-12 View
510(k) K223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws HRS 2023-09-25 View
510(k) K223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays PHX 2023-09-14 View
510(k) K232002 Vantage® Total Ankle System HSN 2023-09-11 View
510(k) K223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas JWH 2023-07-17 View
510(k) K221323 Exactech® Alteon® Short Tapered Wedge LZO 2023-05-19 View
510(k) K212356 Exactech® Equinoxe® Laser Cage Glenoid KWS 2022-03-04 View
510(k) K192097 Exactech® Equinoxe® Stemless Humeral Components PKC 2020-04-29 View
510(k) K193098 Exactech® Equinoxe® Reverse Shoulder Glenospheres PHX 2020-02-20 View
510(k) K190890 Exactech Alteon Modular Dual Mobility (MDM) System LZO 2019-10-22 View
510(k) K191561 Exactech Equinoxe Humeral Augmented Trays PHX 2019-08-20 View
510(k) K183343 Vantage Total Ankle Flat Cut Talar Components HSN 2019-04-01 View
510(k) K182502 Alteon Acetabular Cup System LPH 2019-03-13 View
510(k) K182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws MBH 2018-11-26 View
510(k) K182462 Exactech Alteon Highly Polished Femoral Stem LZO 2018-11-08 View
510(k) K182536 Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap PHX 2018-10-12 View
510(k) K181794 Truliant Porous Femoral Components MBH 2018-09-28 View
510(k) K181532 Exactech Alteon Monobloc Revision Stem LZO 2018-09-04 View
510(k) K180632 Exactech Equinoxe Small Reverse Shoulder System PHX 2018-07-25 View
510(k) K173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners OQI 2018-03-12 View
510(k) K173388 Exactech Equinoxe Stemless Shoulder PKC 2018-03-09 View
510(k) K171045 Exactech® Truliant™ Line Extensions JWH 2017-04-28 View
510(k) K162732 Exactech® Alteon® HA Femoral Stem MEH 2017-04-26 View
510(k) K162325 Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw PHX 2017-03-06 View
510(k) K162903 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies KWT 2017-02-27 View
510(k) K170240 Truliant Femoral Components JWH 2017-02-23 View
510(k) K162726 Exactech® Equinoxe® Preserve Stem PHX 2017-02-01 View
PMA P050039 Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented MRA 2016-09-28 View
510(k) K153649 Exactech® Novation® Element Press-fit Femoral Stem MEH 2016-08-31 View
510(k) K160697 Gibralt® Spine System and Gibralt® Occipital Spine System NKG 2016-06-28 View
510(k) K153595 Optetrak Logic Metaphyseal Cones JWH 2016-03-25 View
510(k) K160484 Optetrak Advanced Patella JWH 2016-03-18 View
510(k) K152217 Exactech Vantage Total Ankle System HSN 2016-03-10 View
510(k) K153776 Optetrak One Logic Femoral Components MBH 2016-03-10 View
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