510(k) K180580

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices by Surgical Instrument Service and Savings, Inc. — Product Code KTT

K180580 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings, Inc. for the device "Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices". The FDA issued a decision of Substantially Equivalent on July 27, 2018. 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.