Medical Device Manufacturer · CN , Tianjin

Tianjin Zhengtian Medical Instrument Co., Ltd. - FDA 510(k) Cleared D...

3 submissions · 3 cleared · Since 2016

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tianjin Zhengtian Medical Instrument Co., Ltd. Orthopedic ✕

3 devices

1-3 of 3

Cleared Mar 06, 2018

IRENE Thoracolumbar Fixation System

Orthopedic · 222d

Cleared Oct 23, 2017

IRENE Cannulated Screw System

Orthopedic · 290d

Cleared Feb 25, 2016

IRENE Locking Compression Plate System

Orthopedic · 266d