510(k) K952298

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE by J.B.S., S.A. — Product Code MNH

K952298 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "SPINAL PEDICLE SCREW, FIXATION, APPLIANCE". The FDA issued a decision of Substantially Equivalent for Some Indications on Dec 13, 1995. 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.