510(k) K991678

WHITESIDE BIOMECHANICS SPINAL SYSTEM by Whiteside Biomechanics, Inc. — Product Code KWQ

K991678 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "WHITESIDE BIOMECHANICS SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 12, 1999. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.