510(k) K220260

Hercules Syndesmosis Implant System by In2bones USA, LLC — Product Code HTN

K220260 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "Hercules Syndesmosis Implant System". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. In2bones USA, LLC has at least 10 other 510(k) clearances on record.