510(k) K163303

OsteoMed ExtremiFix Mid and Large Screw System by Osteomed, LLC — Product Code HWC

K163303 is an FDA 510(k) premarket notification submitted by Osteomed, LLC for the device "OsteoMed ExtremiFix Mid and Large Screw System". The FDA issued a decision of Substantially Equivalent on April 4, 2017. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Osteomed, LLC has at least 10 other 510(k) clearances on record.