510(k) K211932

Fixxsure Anterior Lumbar Plate and Screw System by Oak Tree Engineering, LLC — Product Code KWQ

K211932 is an FDA 510(k) premarket notification submitted by Oak Tree Engineering, LLC for the device "Fixxsure Anterior Lumbar Plate and Screw System". The FDA issued a decision of Substantially Equivalent on Jul 27, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Oak Tree Engineering, LLC has 1 other 510(k) clearance on record.