510(k) K212912

OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System by B-One Ortho, Corp. — Product Code MAI

K212912 is an FDA 510(k) premarket notification submitted by B-One Ortho, Corp. for the device "OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System". The FDA issued a decision of Substantially Equivalent on November 4, 2021. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. B-One Ortho, Corp. has at least 10 other 510(k) clearances on record.