Medical Device Manufacturer · FR , Besan?on

Onefit Medical - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2014

Recent clearances: hipEOS, kneeEOS, hipEOS

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Onefit Medical Radiology ✕

5 devices

1-5 of 5

Cleared Apr 27, 2018

Radiology · 179d

Cleared Oct 03, 2016

Radiology · 90d

Cleared Jun 28, 2016

Radiology · 28d

Cleared Apr 08, 2016

Radiology · 52d

Cleared Dec 05, 2014

ONEFIT HIP PLANNER

Radiology · 77d