510(k) K254176

SINEFIX by BAAT Medical Products B.V. — Product Code MBI

K254176 is an FDA 510(k) premarket notification submitted by BAAT Medical Products B.V. for the device "SINEFIX". The FDA issued a decision of Substantially Equivalent on March 16, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. BAAT Medical Products B.V. has at least 4 other 510(k) clearances on record.