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510(k) K172871

SpineKure Kyphoplasty System by Hanchang Co., Ltd. — Product Code NDN

K172871 is an FDA 510(k) premarket notification submitted by Hanchang Co., Ltd. for the device "SpineKure Kyphoplasty System". The FDA issued a decision of Substantially Equivalent on May 29, 2018. 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
May 29, 2018
Date Received
September 21, 2017
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

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FDA data resources