510(k) K052763

STELLA CERVICAL PLATE by Scient'X — Product Code KWQ

K052763 is an FDA 510(k) premarket notification submitted by Scient'X for the device "STELLA CERVICAL PLATE". The FDA issued a decision of Substantially Equivalent on November 10, 2005. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Scient'X has at least 10 other 510(k) clearances on record.