510(k) K132412

INERTIA MIS PEDICLE SCREW SYSTEM by Nexxt Spine, LLC — Product Code MNI

K132412 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "INERTIA MIS PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on October 10, 2013. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.