510(k) K171911

Medline ReNewal Reprocessed Synthes External Fixation Systems by Surgical Instrument Service and Savings, Inc. — Product Code KTT

K171911 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings, Inc. for the device "Medline ReNewal Reprocessed Synthes External Fixation Systems". The FDA issued a decision of Substantially Equivalent on November 9, 2017. 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. Surgical Instrument Service and Savings, Inc. has at least 10 other 510(k) clearances on record.