510(k) K221947

Tyber Medical Staple Fixation System (various) by Tyber Medical, LLC — Product Code JDR

K221947 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical Staple Fixation System (various)". The FDA issued a decision of Substantially Equivalent on October 20, 2022. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tyber Medical, LLC has at least 10 other 510(k) clearances on record.