Medline ReNewal Reprocessed Stryker External Fixation Devices

Medline ReNewal Reprocessed Stryker External Fixation Devices is an FDA 510(k)-cleared medical device (K163028) manufactured by Surgical Instrument Service and Savings, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 27, 2016. Regulation: 8.