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Medical equipment / Food and Drug Administration / Shoulder / Implants / Rotator cuff / Humerus / Upper extremity of humerus / Glenohumeral joint / Premarket approval / Human anatomy / Anatomy / Medicine


K140904 (page 1/1) K140904
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Document Date: 2014-06-06 11:54:39

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City

Metric Boulevard Austin / /

Company

Encore Medical L.P. / K 140904 Trade / /

Event

Product Issues / FDA Phase / /

/

IndustryTerm

metal/polymer / metal / announcements concerning your device / predicate devices / Internet address hitp /

MedicalCondition

Fatigue / /

MedicalTreatment

joint replacement / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Device Evaluation Center for Devices and Radiological Health Enclosure K140904 / office of Device Evaluation / FDA / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division / CDRH's office of Surveillance / /

Person

Teffany Hutto / Lori A.Wiggins / Teffiany Hutto / Mark N. Melkerson / /

/

Position

Manager / Regulatory Affairs / Manager / Regulatory Affairs Phone / /

Product

Federal Food / rotator cuff shoulderjoint / rotator cuff shoulder joint / rotator cuff / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / fundamental scientific technology / /

URL

www.fda~pov/MedicaiDevices/RsourcesforYou/Iidustry/derault.html / http /

SocialTag