510(k) K023644

MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM by Spinal Concepts, Inc. — Product Code MNI

K023644 is an FDA 510(k) premarket notification submitted by Spinal Concepts, Inc. for the device "MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 2002. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Spinal Concepts, Inc. has at least 10 other 510(k) clearances on record.