510(k) K103505

ALTUM ANTERIOR CERVICAL PLATE by Spinecraft, LLC — Product Code KWQ

K103505 is an FDA 510(k) premarket notification submitted by Spinecraft, LLC for the device "ALTUM ANTERIOR CERVICAL PLATE". The FDA issued a decision of Substantially Equivalent on March 15, 2011. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinecraft, LLC has at least 10 other 510(k) clearances on record.