510(k) K190231

InCore® Lapidus Sterile Kits by Nextremity Solutions, Inc. — Product Code HWC

K190231 is an FDA 510(k) premarket notification submitted by Nextremity Solutions, Inc. for the device "InCore® Lapidus Sterile Kits". The FDA issued a decision of Substantially Equivalent on May 24, 2019. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nextremity Solutions, Inc. has at least 10 other 510(k) clearances on record.