510(k) K253042

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

K253042 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical Trauma Screw". The FDA issued a decision of Substantially Equivalent on April 3, 2026. 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.