510(k) K201883

6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor by Medos International SARL — Product Code MBI

K201883 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor". The FDA issued a decision of Substantially Equivalent on Aug 7, 2020. 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 95 other 510(k) clearances on record.