510(k) K111792

MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI by Signus Medizintechnik GmbH — Product Code MAX

K111792 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI". The FDA issued a decision of Substantially Equivalent on March 5, 2012. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.