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Orthopedic surgery / Traumatology / Implants / Radius / Humerus / Internal fixation / Child bone fracture / Medicine / Bone fractures / Long bones


K[removed]Page I of 2) -APR Date Summary Prepared September 12, 2012 ManufacturerlDistributor/Sponsor Arthrex, Inc.
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Document Date: 2013-05-06 11:19:35


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City

Creekside Boulevard Naples / Naples / /

Company

K123241 Trade / Regulatory Affairs Arthrex Inc. / Synthes / Stainless Steel / Arthrex Inc. / ManufacturerlDistributor/Sponsor Arthrex Inc. / /

Country

United States / /

Event

FDA Phase / /

Facility

New Hamrpshire Avenue Documnent Control Center / /

/

IndustryTerm

Internet address http /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / office of Device Evaluation / office of Surveillance / Division of Orthopedic Devices Page / Division of Orthopedic Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / New Hamrpshire Avenue Documnent Control Center / Device Evaluation Center for Devices and Radiological Health Enclosure Page / /

Person

Silver Spring / Elizabeth L. Frank / Courtney Smith / Mark N. Melkerson / /

/

Position

Manager / /

Product

Federal Food / /

ProgrammingLanguage

FL / K / /

ProvinceOrState

Maryland / Florida / /

Technology

radiation / /

URL

http /

SocialTag