510(k) K173885

Genesys Spine Binary Lumbar Plate System by Genesys Spine — Product Code KWQ

K173885 is an FDA 510(k) premarket notification submitted by Genesys Spine for the device "Genesys Spine Binary Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on April 3, 2018. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Genesys Spine has at least 10 other 510(k) clearances on record.