510(k) K232315

Catalyst Bone Void Filler by Ossdsign AB — Product Code MQV

K232315 is an FDA 510(k) premarket notification submitted by Ossdsign AB for the device "Catalyst Bone Void Filler". The FDA issued a decision of Substantially Equivalent on September 15, 2023. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Ossdsign AB has at least 5 other 510(k) clearances on record.