510(k) K073232

INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX by Spinefrontier, Inc. — Product Code KWQ

K073232 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX". The FDA issued a decision of Substantially Equivalent on Feb 20, 2008. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinefrontier, Inc. has 23 other 510(k) clearances on record.