510(k) K192096

Omnia Medical Trauma Screws by Omnia Medical, LLC — Product Code HWC

K192096 is an FDA 510(k) premarket notification submitted by Omnia Medical, LLC for the device "Omnia Medical Trauma Screws". The FDA issued a decision of Substantially Equivalent on February 27, 2020. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Omnia Medical, LLC has at least 10 other 510(k) clearances on record.