510(k) K093776

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

K093776 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "INDUS ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 26, 2010. 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 at least 10 other 510(k) clearances on record.