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510(k) K162283

DCM Kyphoplasty System by Dragon Crown Medical Co., Ltd. — Product Code NDN

K162283 is an FDA 510(k) premarket notification submitted by Dragon Crown Medical Co., Ltd. for the device "DCM Kyphoplasty System". The FDA issued a decision of Substantially Equivalent on Feb 6, 2017. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 6, 2017
Date Received
Aug 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type
510(k)

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FDA data resources