DCM Kyphoplasty System

Cement, Bone, Vertebroplasty

Dragon Crown Medical Co., Ltd.

The following data is part of a premarket notification filed by Dragon Crown Medical Co., Ltd. with the FDA for Dcm Kyphoplasty System.

Pre-market Notification Details

Device IDK162283
510k NumberK162283
Device Name:DCM Kyphoplasty System
ClassificationCement, Bone, Vertebroplasty
Applicant Dragon Crown Medical Co., Ltd. 6F, Kehui Building, No. 109, Shunhua Road High-Tech Development Zone Jinan,  CN 250101
ContactZhi Yong Song
CorrespondentZhi Yong Song
Dragon Crown Medical Co., Ltd. 6F, Kehui Building, No. 109, Shunhua Road High-Tech Development Zone Jinan,  CN 250101
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-15
Decision Date2017-02-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.