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Arthroplasty / Premarket approval / Saint-Ismier / Medical device / Upper extremity of humerus / Glenoid cavity / Center for Devices and Radiological Health / Federal Food / Drug / and Cosmetic Act / Glenohumeral joint / Medicine / Food and Drug Administration / Shoulder replacement


I D-_NOV - TORNIER Chirurgicaux
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Document Date: 2011-12-26 00:34:08

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File Size: 242,83 KB

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Company

Tornier Inc. / Saint-Ismier France / SAINT-ISMIER S.A.S. / Shoulder Total Shoulder Gamma Tornier Gamma Tornier Inc. / Aequalis Press / TORNIER SA. / K111902 Trade / Lavoisier - Morubonnot 38334 SA / Applicant Tornier Inc. / /

Country

France / /

Currency

USD / GBP / /

Event

FDA Phase / /

/

IndustryTerm

cement layer thickness / humeral head systems / announcements concerning your device / predicate devices / manufacturing practice requirements / cited predicate devices / cement / marketed predicate devices / joint metal/polymer / manufacturing practice / Internet address http /

Organization

Division of Postmarket Surveillance / jrMark N. Melkerson Director Division of Surgical / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic / and Restorative Devices Office / CDRH's office of Surveillance / Division of Surgical / /

Person

Severine Bonneton / Silyer Spring / /

/

Position

humeral head / Regulatory affairs Specialist / /

Product

S.A.S / Federal Food / /

ProgrammingLanguage

E / /

Technology

radiation / http / /

URL

http /

SocialTag