510(k) K901272

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY by Med-Tek Corp. — Product Code KTT

K901272 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "ORION BLADE PLATE FOR TIBIAL OSTEOTOMY". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Med-Tek Corp. has at least 10 other 510(k) clearances on record.