510(k) K243790

GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor by Depuy Mitek — Product Code MAI

K243790 is an FDA 510(k) premarket notification submitted by Depuy Mitek for the device "GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor". The FDA issued a decision of Substantially Equivalent on February 5, 2025. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek has at least 10 other 510(k) clearances on record.