510(k) K240084

V-STRUT® Vertebral Implant by Hyprevention — Product Code NDN

K240084 is an FDA 510(k) premarket notification submitted by Hyprevention for the device "V-STRUT® Vertebral Implant". The FDA issued a decision of Substantially Equivalent on February 9, 2024. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Hyprevention has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2024
Date Received
January 11, 2024
Clearance Type
Special
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