510(k) K190774

RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant by Medos International SARL — Product Code MBI

K190774 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant". The FDA issued a decision of Substantially Equivalent on Jul 25, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medos International SARL has 95 other 510(k) clearances on record.