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Food law / Bone fractures / Orthopedic surgery / Clavicle fracture / Pharmaceuticals policy / Medical device / Premarket approval / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Health / Food and Drug Administration


K140259 510(k) Summary Proprietary Name: VariAx Clavicle Hook Plate
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Document Date: 2014-05-07 12:37:02

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File Size: 119,53 KB

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City

Corporate Drive Mahwah / /

Company

AAP / Synthes / Stryker Trauma AG / K140259 Trade / /

Country

United States / /

Event

FDA Phase / /

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IndustryTerm

announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address lhttp /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / office of Device Evaluation / Division of Orthopedic Devices Page / FDA / 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 / CDRH's office of Surveillance / /

Person

Lori A.Wiggins / Elizabeth L. Frank / Elijah N. Wreb / Mark N. Melkerson / Elijah N. Wreh / /

/

Position

Regulatory Affairs Specialist / /

Product

Federal Food / 2I1CFR / /

ProvinceOrState

New Jersey / /

Technology

radiation / /

URL

http /

SocialTag