510(k) K042798

C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM by Interpore Cross Intl. — Product Code KWQ

K042798 is an FDA 510(k) premarket notification submitted by Interpore Cross Intl. for the device "C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 4, 2004. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Interpore Cross Intl. has at least 10 other 510(k) clearances on record.