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510(k) K192403

VK100 Percutaneous Vertebral Augmentation System by Bonwrx, Ltd. — Product Code NDN

K192403 is an FDA 510(k) premarket notification submitted by Bonwrx, Ltd. for the device "VK100 Percutaneous Vertebral Augmentation System". The FDA issued a decision of Substantially Equivalent on November 8, 2019. 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
November 8, 2019
Date Received
September 3, 2019
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