510(k) K183588

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System by Choicespine — Product Code MQP

K183588 is an FDA 510(k) premarket notification submitted by Choicespine for the device "Choice Spine Hawkeye Vertebral Body Replacement (VBR) System". The FDA issued a decision of Substantially Equivalent on February 22, 2019. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Choicespine has at least 10 other 510(k) clearances on record.