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510(k) K250556

Porous Biologic Scaffold by Ventris Medical — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
February 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Ventris Medical

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  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
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  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)