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Humerus fracture / Upper extremity of humerus / Medical device / Humerus / Center for Devices and Radiological Health / Premarket approval / Nonunion / Bone / Federal Food /  Drug /  and Cosmetic Act / Medicine / Food and Drug Administration / Bone fractures


Page I of 2 K133668[removed]k) Summary
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Document Date: 2014-04-10 10:15:45


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City

Waxhaw / /

Company

Synthes / Shoulder Options Inc. / Applicant Shoulder Options Inc. / K133668 Trade / /

Currency

pence / /

Event

FDA Phase / /

/

IndustryTerm

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

Organization

Orthopedic Devices Office / CDR.H's office of Surveillance / Division of Postmarket Surveillance / New Hampsbire Avenue Document Conrowl Center / office of Device Evaluation / 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 / /

Person

John Kapitan / Mark N. Melkerson / /

/

Position

CEO / /

Product

Administrationi / Federal Food / /

ProvinceOrState

Maryland / North Carolina / /

Technology

radiation / /

URL

http /

SocialTag