510(k) K243760

OSSIOfiber® Suture Anchor 2.5-3.5 mm by OSSIO , Ltd. — Product Code MAI

K243760 is an FDA 510(k) premarket notification submitted by OSSIO , Ltd. for the device "OSSIOfiber® Suture Anchor 2.5-3.5 mm". The FDA issued a decision of Substantially Equivalent on April 3, 2025. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. OSSIO , Ltd. has at least 10 other 510(k) clearances on record.