510(k) K962757

J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP by J.B.S., S.A. — Product Code MNH

K962757 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP". The FDA issued a decision of Substantially Equivalent on Sep 25, 1996. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. J.B.S., S.A. has 9 other 510(k) clearances on record.