510(k) K071668

ORTHOBIOM SPINAL SYSTEM by Paradigm Spine — Product Code MNI

K071668 is an FDA 510(k) premarket notification submitted by Paradigm Spine for the device "ORTHOBIOM SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2008. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Paradigm Spine has at least 10 other 510(k) clearances on record.