510(k) K163028

Medline ReNewal Reprocessed Stryker External Fixation Devices by Surgical Instrument Service and Savings, Inc. — Product Code JEC

K163028 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings, Inc. for the device "Medline ReNewal Reprocessed Stryker External Fixation Devices". The FDA issued a decision of Substantially Equivalent on December 28, 2016. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Surgical Instrument Service and Savings, Inc. has at least 10 other 510(k) clearances on record.