510(k) K233089

NeoSpan® Compression Implant System by In2bones USA, LLC — Product Code HRS

K233089 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "NeoSpan® Compression Implant System". The FDA issued a decision of Substantially Equivalent on May 24, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones USA, LLC has at least 10 other 510(k) clearances on record.