510(k) K081332

ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM by Signus Medizintechnik GmbH — Product Code MQP

K081332 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 10, 2008. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.