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Food and Drug Administration / Premarket approval / Medical device / Center for Devices and Radiological Health / Fibular collateral ligament / Radial collateral ligament of elbow joint / Knee / Medial collateral ligament / Elbow / Anatomy / Medicine / Human anatomy


K130458[removed]AiftaW&0 510(K): ARThREX KNOTLESS FIBERTA< SUTFURE ANCHOR Date Summry Prepared Manufacturer/Distributor/Sponsor
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Document Date: 2013-06-10 14:13:20

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File Size: 158,96 KB

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City

Creekside Boulevard Naples / Naples / /

Company

Arthrex Inc. / K130458 Trade / Contact Christina Flores Regulatory Affairs Specialist Artlirex Inc. / /

Country

United States / /

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Facility

Newv Hampshire Avenue Document Control Center / /

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IndustryTerm

announcements concerning your device / predicate devices / soft-tissu~e fixation device / Internet address http /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Newv Hampshire Avenue Document Control Center / Food and Drug Administration / CDRH' s office of Surveillance / office of Device Evaluation / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / Device Evaluation Center for Devices and Radiological Health Enclosure / /

Person

Silver Spring / Christina Flores / Mark N. Melkerson / /

/

Position

Regulatory Affairs Specialist / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

radiation / http / /

URL

http /

SocialTag