510(k) K072231

THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) by Esm Technologies, LLC — Product Code KWQ

K072231 is an FDA 510(k) premarket notification submitted by Esm Technologies, LLC for the device "THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)". The FDA issued a decision of Substantially Equivalent on Dec 26, 2007. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Esm Technologies, LLC has 1 other 510(k) clearance on record.