510(k) K080815

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM by Signus Medizintechnik GmbH — Product Code KWQ

K080815 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "TOSCA II ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 2008. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.