510(k) K160522

White Pearl Preferred Angle Anterior Cervical Plate by Osseus Fusion Systems, LLC — Product Code KWQ

K160522 is an FDA 510(k) premarket notification submitted by Osseus Fusion Systems, LLC for the device "White Pearl Preferred Angle Anterior Cervical Plate". The FDA issued a decision of Substantially Equivalent on Apr 26, 2016. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Osseus Fusion Systems, LLC has 9 other 510(k) clearances on record.