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510(k) Summary Sponsor Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
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Document Date: 2011-04-25 00:29:55

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City

Drive Mahwah / Corporate Drive Mahwah / Mahwah / /

Company

Regulatory Compliance 325 Corporate Drive Mahwah / Summary Sponsor Howmedica Osteonics Corp. / Howmedica Osteonics Corp. / K102019 Trade / Regulatory Affairs/Regulatory Compliance Howmedica Osteonics Corp. / /

Event

FDA Phase / /

IndustryTerm

metal/polymer / joint metal/polymer/metal semi / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / marketed predicate devices / cup using bone cement / Internet address htp/wwfagvMdcleie/esucso~uIiutydfuthm Sincerely / /

Organization

Mark N. Melkero Director Division of Surgical / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Device Evaluation Center for Devices / office of Surveillance and Biometrics/Di / Division of Small Manufacturers / International and Consumer Assistance / HUMAN SERVICES Public Health Service DEPARMENTFood and Drug Administration / Restorative Devices Office / /

Person

Mark N. Melkero / Karen Ariemnma / Karen Ariemma / Silver Spring / /

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Position

Project Manager / General / general information onl / 25il1 Project Manager / /

Product

Federal Food / 2I1CFR / /

ProvinceOrState

New Jersey / Maryland / /

Technology

radiation / /

URL

www.fda.Vov/AboutF / /

SocialTag