510(k) K102853

FLAMENCO SPINAL FIXATION SYSTEM by Ulrich GmbH & Co. KG — Product Code MNH

K102853 is an FDA 510(k) premarket notification submitted by Ulrich GmbH & Co. KG for the device "FLAMENCO SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 25, 2011. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Ulrich GmbH & Co. KG has at least 10 other 510(k) clearances on record.