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Prosthetics / Pelvis / Arthropathies / Hip replacement / Arthroplasty / Hip / Coxa vara / Medical device / Coxa valga / Medicine / Orthopedic surgery / Implants


Document Date: 2011-05-30 00:45:11

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City

El Dorado Hills / /

Company

Ceramic Ball Hip Systems / Haycs Medical Inc. / Consensus Orthopedics Inc. / Hayes Medical Inc. / K110542 Trade / CeramTec AG / /

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Event

FDA Phase / /

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IndustryTerm

announcements 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 / /

MedicalCondition

D. Avascular necrosis / D. Avaseular necrosis / post-traumatic arthritis / osteomalacia / osteoporosis / coxa Plana / /

MedicalTreatment

hip surgery / /

Organization

Orthopedic 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 / /

Person

Matthew M. Hull / /

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Position

CONSENSUS 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 / /

Product

Federal Food / /

Technology

radiation / http / /

URL

www.t'da.tov/MedicalDevices/Safety/ReportaPr-obleii/defhuIt.htim / www.fda.g!ov/AboutFDA/CentersOflices/CDRHl/CDRI-10ffices/ucn / /

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