510(k) K220765

HS Fiber Cerclage by Riverpoint Medical, LLC — Product Code JDQ

K220765 is an FDA 510(k) premarket notification submitted by Riverpoint Medical, LLC for the device "HS Fiber Cerclage". The FDA issued a decision of Substantially Equivalent on July 26, 2023. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Riverpoint Medical, LLC has at least 10 other 510(k) clearances on record.