510(k) K232513

X-Twist Biocomposite Suture Anchor by Parcus Medical — Product Code MAI

K232513 is an FDA 510(k) premarket notification submitted by Parcus Medical for the device "X-Twist Biocomposite Suture Anchor". The FDA issued a decision of Substantially Equivalent on September 18, 2023. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Parcus Medical has at least 10 other 510(k) clearances on record.