510(k) K781444

OUTRIGGER DISTRACTION UNIT by Orthopedic Equipment Co., Inc. — Product Code KWP

K781444 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "OUTRIGGER DISTRACTION UNIT". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.