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510(k) K240084

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

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

Other clearances by Hyprevention

  • K191709 — V-STRUT Vertebral Implant (March 5, 2020)

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