510(k) K181958

MagnetOs Putty by Kuros Biosciences B.V — Product Code MQV

K181958 is an FDA 510(k) premarket notification submitted by Kuros Biosciences B.V for the device "MagnetOs Putty". The FDA issued a decision of Substantially Equivalent on December 6, 2018. 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
December 6, 2018
Date Received
July 23, 2018
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