UHR Bipolar Implants, Restoration GAP II Implants

UHR Bipolar Implants, Restoration GAP II Implants is an FDA 510(k)-cleared medical device (K222632) manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 2022. Regulation: 8.