510(k) K261869

Integrity Retractable Implant Inserter (6000127) by Anika Therapeutics, Inc. — Product Code MBI

K261869 is an FDA 510(k) premarket notification submitted by Anika Therapeutics, Inc. for the device "Integrity Retractable Implant Inserter (6000127)". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Anika Therapeutics, Inc. has at least 10 other 510(k) clearances on record.