Mako Surgical is one of 18575 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Mako Surgical - FDA 510(k) Cleared Devices
Recent clearances: KINETIS Total Knee System
1
Total
1
Cleared
0
Denied
Mako Surgical, is an orthopedic device company with a manufacturing facility in Fort Lauderdale, US. The company specializes in robotic-assisted surgical systems for joint replacement procedures.
Mako Surgical received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity is focused on orthopedic devices, with its first and only clearance granted in 2015. The company is currently inactive and represents a historical record in the FDA 510(k) database.
The KINETIS Total Knee System was the company's cleared orthopedic device, representing advanced surgical technology for knee replacement. Explore the device name, product code, and clearance date in the full regulatory record.
FDA 510(k) Regulatory Record - Mako Surgical
1 devices