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Osteology / Bone fractures / Orthopedic surgery / Implants / Traumatology / Internal fixation / Radius / Ulna / Humerus / Medicine / Anatomy / Long bones


K1[removed]page 1 of 3 RY QFVSNESS M Date Summary Prepared May 15, 2013
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Document Date: 2013-08-06 11:28:37


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City

Creekside Boulevard Naples / Naples / /

Company

Arthrex Incorporated / K131474 Trade / Contact ICourtneySmith Regulatory Affairs Manager Arthrex Inc. / Distributor/Sponsor JL021 Arthrex Inc. / /

Country

United States / /

Event

FDA Phase / /

Facility

New Hamnpshire Avenue Document Control Center / /

/

IndustryTerm

thle quality systems / announcements concerning your device / predicate devices / predicate device / Internet address htto /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / New Hamnpshire Avenue Document Control Center / office of Device Evaluation / Device Evaluation Center for Devices and Radiological HeIalth / FDA / CORIl's office of Surveillance / SSof1 Division / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / /

Person

Courtney Smith / Mark N. Melkerson / /

/

Position

Regulatory Affairs Manager / general information onl / /

Product

Federal Food / K123875 / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

radiation / /

URL

www.fda.alov/Mcdica / http /

SocialTag