510(k) K212990

Acumed Ankle Syndesmosis Repair System by Acumed, LLC — Product Code HTN

K212990 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "Acumed Ankle Syndesmosis Repair System". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Acumed, LLC has at least 10 other 510(k) clearances on record.