510(k) K213959

MagnetOs Flex Matrix by Kuros Biosciences B.V — Product Code MQV

K213959 is an FDA 510(k) premarket notification submitted by Kuros Biosciences B.V for the device "MagnetOs Flex Matrix". The FDA issued a decision of Substantially Equivalent on April 14, 2022. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Kuros Biosciences B.V has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2022
Date Received
December 17, 2021
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