510(k) K170530

Butrex Lumbar Buttress Plating System by X-Spine Systems, Inc. — Product Code KWQ

K170530 is an FDA 510(k) premarket notification submitted by X-Spine Systems, Inc. for the device "Butrex Lumbar Buttress Plating System". The FDA issued a decision of Substantially Equivalent on March 22, 2017. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. X-Spine Systems, Inc. has at least 10 other 510(k) clearances on record.