Division of Postmarket Surveillance / Food and Drug Administration / Orthopedic Devices office of Device Evaluation / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Mark N.Melkerson Mark N. Melkerson Director Division / Division of Orthopedic Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Center for Devices / /
Person
Anton E. Dmitriev / Mark N. Melkerson / Brahim Hadri Sr. / Brahim Hadri / / /
Position
compatible humeral head / humeral head / Regulatory affairs Specialist / Senior Regulatory Affairs Specialist / /
JAN[removed]SECTION 5: 510(K) PREMARKET NOTIFICATION Summary of Safety and Effectiveness information Tornier AequalisTM AscendTM Flex Shoulder System Regulatory authority: Safe Medical Devices Act of 1990, 21 CER[removed]