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Implants / Prosthetics / Shoulder replacement / Joints / Rotator cuff / Glenohumeral joint / Glenoid cavity / Medical device / Anatomy / Medicine / Shoulder


K133349 (page 1/3) JUN[removed]Summary of Safety and Effectiveness
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Document Date: 2014-07-18 16:16:25


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File Size: 176,87 KB

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Company

Reverse Shoulder Systems / Limacorporate S.p.A. / K133349 Trade / DePuy / /

Event

Product Issues / FDA Phase / /

Facility

Lodge Pole Lane Fort Wayne / /

IndustryTerm

subject device / metal / thle quality systems / joint metal/polymer semiTotal orShoulder / predicate devices / ftirther announcements concerning your device / bone cement / manufacturing practice requirements / Internet address http /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Limacorporate Sp.A / Division of Industry and Consumer Education / office of Device Evaluation / FDA / Device Evaluation Center for Devices / Mark N. Melkerson Director Division / CDRH's office of Surveillance / /

Person

Ronald P.Jean / Mark N. Melkerson / /

/

Position

Stephen J. Peoples Principal Consultant / humeral head / /

Product

Federal Food / joint / /

ProvinceOrState

Indiana / /

Technology

radiation / /

URL

www.fda.aov/MedicalDevices/ResoturccsforYou/lndustrv/defaulthtm / http /

SocialTag