Metallic Locking Bone Plate And Screw

Plate, Fixation, Bone

Canwell Medical Co., Ltd

The following data is part of a premarket notification filed by Canwell Medical Co., Ltd with the FDA for Metallic Locking Bone Plate And Screw.

Pre-market Notification Details

Device IDK142943
510k NumberK142943
Device Name:Metallic Locking Bone Plate And Screw
ClassificationPlate, Fixation, Bone
Applicant Canwell Medical Co., Ltd No.329 Yongkang Street Jinhua,  CN 321015
ContactChen Hui
CorrespondentMike Gu
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. 7th Floor Jingui Business Buildng No. 982 Cogyuan Rd BAIYUN DISTRICT Guangzhou,  CN 510420
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-10
Decision Date2015-08-03
Summary:summary

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