Point Robotics MedTech, Inc. - FDA 510(k) Cleared Devices
Recent clearances: “POINT” Kinguide Agile Hybrid Navigation System, POINT Kinguide Agile Robotic Arm Surgical Stereotactic System, “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Point Robotics MedTech, Inc. Orthopedic ✕
5 devices
Cleared
Feb 20, 2026
“POINT” Kinguide Agile Hybrid Navigation System
Orthopedic
155d
Cleared
Jan 23, 2026
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
Orthopedic
147d
Cleared
Jul 24, 2024
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
Orthopedic
91d
Cleared
Jul 17, 2023
“POINT” Kinguide Agile Hybrid Navigation System
Orthopedic
186d
Cleared
Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
Orthopedic
193d