510(k) K990158

OSTEONICS COMBINATION SCREW RING/BLOCKER by Osteonics Corp. — Product Code MNI

K990158 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS COMBINATION SCREW RING/BLOCKER". The FDA issued a decision of Substantially Equivalent on February 1, 1999. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Osteonics Corp. has at least 10 other 510(k) clearances on record.