510(k) K231236

IBS-B MIS Beveled Screw System by In2bones USA, LLC — Product Code HWC

K231236 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "IBS-B MIS Beveled Screw System". The FDA issued a decision of Substantially Equivalent on July 27, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. In2bones USA, LLC has at least 10 other 510(k) clearances on record.