510(k) K233490

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty by Bioventus, LLC — Product Code MQV

K233490 is an FDA 510(k) premarket notification submitted by Bioventus, LLC for the device "SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty". The FDA issued a decision of Substantially Equivalent on December 5, 2023. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bioventus, LLC has at least 5 other 510(k) clearances on record.