510(k) K061978

EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM by Ebi, L.P. — Product Code MNI

K061978 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 11, 2006. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Ebi, L.P. has at least 10 other 510(k) clearances on record.