510(k) K101151

REGENT ANTERIOR CERVICAL PLATE by Custom Spine — Product Code KWQ

K101151 is an FDA 510(k) premarket notification submitted by Custom Spine for the device "REGENT ANTERIOR CERVICAL PLATE". The FDA issued a decision of Substantially Equivalent on May 19, 2010. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Custom Spine has at least 10 other 510(k) clearances on record.