510(k) K090861

MAMBO, MODEL CS 18XX-XX by Ulrich GmbH & Co. KG — Product Code KWQ

K090861 is an FDA 510(k) premarket notification submitted by Ulrich GmbH & Co. KG for the device "MAMBO, MODEL CS 18XX-XX". The FDA issued a decision of Substantially Equivalent on May 21, 2010. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Ulrich GmbH & Co. KG has at least 10 other 510(k) clearances on record.