510(k) K211695

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

K211695 is an FDA 510(k) premarket notification submitted by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices for the device "Valkyrie Thoracic Fixation System". The FDA issued a decision of Substantially Equivalent on June 23, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices has at least 1 other 510(k) clearance on record.