510(k) K984522

MODIFICATION OF TSRH SPINAL SYSTEM by Danek Medical, Inc. — Product Code MNI

K984522 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "MODIFICATION OF TSRH SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 6, 1999. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.