510(k) K190375

Parcus ATLAS by Parcus Medical, LLC — Product Code MBI

K190375 is an FDA 510(k) premarket notification submitted by Parcus Medical, LLC for the device "Parcus ATLAS". The FDA issued a decision of Substantially Equivalent on Apr 24, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Parcus Medical, LLC has at least 10 other 510(k) clearances on record.