510(k) K231903

Montage-QS Settable, Resorbable Bone Putty by Orthocon, Inc. — Product Code MQV

K231903 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Montage-QS Settable, Resorbable Bone Putty". The FDA issued a decision of Substantially Equivalent on August 25, 2023. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Orthocon, Inc. has at least 10 other 510(k) clearances on record.