510(k) K231326

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) by Osteonic Co., Ltd. — Product Code MAI

K231326 is an FDA 510(k) premarket notification submitted by Osteonic Co., Ltd. for the device "Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)". The FDA issued a decision of Substantially Equivalent on May 31, 2023. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Osteonic Co., Ltd. has at least 10 other 510(k) clearances on record.