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Food law / Bone fractures / Medical device / Medical equipment / Medical technology / Federal Food / Drug / and Cosmetic Act / Premarket approval / Distal radius fracture / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration


K1[removed]JAN[removed]Weare smith&nephew Submitted by: Smith &Nephew, Inc.
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Document Date: 2014-02-07 12:52:51

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File Size: 118,88 KB

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City

Memphis / /

Company

K132296 Trade / Smith &Nephew Inc. / Bone Plate System K051735 Smith & Nephew Inc. / /

Event

FDA Phase / /

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IndustryTerm

screw locking technology / inthe quality systems / predicate devices / manufacturing practice requirements / Internet address httnh/wwwv.fda.2ovlMedicalDevices/RcsourccsfbrYoulndustry/defaulthnl Sincerely / ofmedical device / subject devices / firther announcements concerning your device / /

Organization

Orthopedic Devices Office / CORNH's office of Surveillance / Sfor Mark N. Melkerson Directpr Division / office of Device Evaluation / Division of Orthopedic Devices Page / FDA / Division of Small Manufacturers / International and Consumer Assistance / Device Evaluation Center for Devices and Radiological Health / /

Person

Elizabeth L.Frank / Martin Ostmann / Martin Ostmiann / Martin Ostnmann / Mark N. Melkerson Directpr / /

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Position

Regulatory Affairs Specialist / /

Product

Federal Food / K1 / /

ProvinceOrState

Tennessee / Maryland / /

Technology

radiation / Peri-Loc VLP screw locking technology / /

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