510(k) K091134

CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE by Custom Spine, Inc. — Product Code KWQ

K091134 is an FDA 510(k) premarket notification submitted by Custom Spine, Inc. for the device "CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE". The FDA issued a decision of Substantially Equivalent on August 17, 2009. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Custom Spine, Inc. has at least 10 other 510(k) clearances on record.