510(k) K232492

2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor by Medos International SARL — Product Code MBI

K232492 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor". The FDA issued a decision of Substantially Equivalent on October 6, 2023. 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 at least 10 other 510(k) clearances on record.