Comus Locking Plate Systems

Plate, Fixation, Bone

Jiangsu Trauhui Medical Instrument Co.,Ltd.

The following data is part of a premarket notification filed by Jiangsu Trauhui Medical Instrument Co.,ltd. with the FDA for Comus Locking Plate Systems.

Pre-market Notification Details

Device IDK190842
510k NumberK190842
Device Name:Comus Locking Plate Systems
ClassificationPlate, Fixation, Bone
Applicant Jiangsu Trauhui Medical Instrument Co.,Ltd. No.2 Longqing Road, Wujin Hi-Tech Industrial Zone Changzhou,  CN 213168
ContactZhou Yu
CorrespondentMike Gu
Guangzhou Osmunda Medical Device Consulting Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou,  CN 510006
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-01
Decision Date2020-02-03

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