510(k) K202889

Able Medical Devices Valkyrie Thoracic Fixation System by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices — Product Code HRS

K202889 is an FDA 510(k) premarket notification submitted by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices for the device "Able Medical Devices Valkyrie Thoracic Fixation System". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.