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Mako Surgical Corp.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories2
Latest FDA decision2026-02-25
TypeNumberDevice NameCodeDateActions
510(k) K260222 Mako Total Knee ApplicationOLO2026-02-25 View
510(k) K250608 Mako Total Knee Application (3.0); Hybrid Tip PointerOLO2025-04-25 View
510(k) K243751 Mako Total Hip Application 5.0OLO2025-03-05 View
510(k) K242373 Mako Shoulder Application (1.0)OLO2024-11-07 View
510(k) K241011 Mako Total Knee ApplicationOLO2024-06-11 View
510(k) K220930 Restoris Multi-Compartmental Knee SystemHSX2022-06-02 View
510(k) K220459 Mako Total Knee ApplicationOLO2022-04-15 View
510(k) K193515 Mako Total Knee ApplicationOLO2020-07-14 View
510(k) K193128 Mako Total Hip ApplicationOLO2020-02-02 View
510(k) K191998 Mako Total Hip Application, Mako Total Knee ApplicationOLO2019-09-24 View
510(k) K172301 Mako Partial Knee ApplicationOLO2017-11-02 View
510(k) K172219 Mako Total Knee ApplicationOLO2017-09-21 View
510(k) K170891 Mako Partial Knee ApplicationOLO2017-05-24 View
510(k) K170584 Mako Partial Knee ApplicationOLO2017-05-11 View
510(k) K170581 Mako Total Knee ApplicationOLO2017-05-11 View
510(k) K170593 Mako Total Hip ApplicationOLO2017-04-18 View
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