510(k) K240765

Porous Biologic Scaffold by Ventris Medical — Product Code MQV

K240765 is an FDA 510(k) premarket notification submitted by Ventris Medical for the device "Porous Biologic Scaffold". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Ventris Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
March 20, 2024
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