510(k) K243467

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

K243467 is an FDA 510(k) premarket notification submitted by Osteonic Co., Ltd. for the device "Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)". The FDA issued a decision of Substantially Equivalent on December 3, 2024. 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.