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![]() | Document Date: 2011-05-30 00:45:11Open Document File Size: 185,24 KBShare Result on FacebookCityEl Dorado Hills / /CompanyCeramic Ball Hip Systems / Haycs Medical Inc. / Consensus Orthopedics Inc. / Hayes Medical Inc. / K110542 Trade / CeramTec AG / / /EventFDA Phase / / /IndustryTermannouncements concerning your device / Hip joint metal/ceramic/polymer / metal/polymer/metal / manufacturing practice requirements / joint metal/polymer/metal / hip systems / marketed predicate devices / manufacturing practice / Internet address http / /MedicalConditionD. Avascular necrosis / D. Avaseular necrosis / post-traumatic arthritis / osteomalacia / osteoporosis / coxa Plana / /MedicalTreatmenthip surgery / /OrganizationOrthopedic and Restorative Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / office of Surveillance / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Melkerson9 Director Division / /PersonMatthew M. Hull / / /PositionCONSENSUS ZIRCONIA HEAD / Biolox Delta Ceramic Femnoral Head / 22MM COCRMO FEMORAL HEAD / 26MM COCRMO FEMORAL HEAD / CONSENSUS ZIRCONIA FEMORAL HEAD / femoral head / fiemoral head / 32MM COCRMO FEMORAL HEAD / Biolox delta femoral head / BIOLOXfortc ball head / CoCr Fenmoral Head / /ProductFederal Food / /Technologyradiation / http / /URLwww.t'da.tov/MedicalDevices/Safety/ReportaPr-obleii/defhuIt.htim / www.fda.g!ov/AboutFDA/CentersOflices/CDRHl/CDRI-10ffices/ucn / /SocialTag |