510(k) K042073

OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM by Olsen Medical — Product Code KWQ

K042073 is an FDA 510(k) premarket notification submitted by Olsen Medical for the device "OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2005. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Olsen Medical has at least 4 other 510(k) clearances on record.