510(k) K192975

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

K192975 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical Trauma Screws". The FDA issued a decision of Substantially Equivalent on January 9, 2020. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Tyber Medical, LLC has at least 10 other 510(k) clearances on record.