Mako Surgical Corp. - FDA 510(k) Cleared Devices
33
Total
33
Cleared
0
Denied
Mako Surgical Corp. has 33 FDA 510(k) cleared orthopedic devices. Based in Weston, US.
Latest FDA clearance: Feb 2026. Active since 2005.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Mako Surgical Corp.
33 devices
Cleared
Feb 25, 2026
Mako Total Knee Application
Orthopedic
30d
Cleared
Apr 25, 2025
Mako Total Knee Application (3.0)
Orthopedic
56d
Cleared
Mar 05, 2025
Mako Total Hip Application 5.0
Orthopedic
90d
Cleared
Nov 07, 2024
Mako Shoulder Application (1.0)
Orthopedic
90d
Cleared
Jun 11, 2024
Mako Total Knee Application
Orthopedic
60d
Cleared
Jun 02, 2022
Restoris Multi-Compartmental Knee System
Orthopedic
63d
Cleared
Apr 15, 2022
Mako Total Knee Application
Orthopedic
57d
Cleared
Jul 14, 2020
Mako Total Knee Application
Orthopedic
208d
Cleared
Feb 02, 2020
Mako Total Hip Application
Orthopedic
82d
Cleared
Sep 24, 2019
Mako Total Hip Application, Mako Total Knee Application
Orthopedic
60d
Cleared
Nov 02, 2017
Mako Partial Knee Application
Orthopedic
94d
Cleared
Sep 21, 2017
Mako Total Knee Application
Orthopedic
59d