510(k) K253027

Anchor with Fiber Wire and Disposable Inserter by Ortobio S.A. — Product Code MBI

K253027 is an FDA 510(k) premarket notification submitted by Ortobio S.A. for the device "Anchor with Fiber Wire and Disposable Inserter". The FDA issued a decision of Substantially Equivalent on May 6, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040.