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Medical equipment / Orthopedic surgery / Implants / Arthritis / Shoulder / Arthroplasty / Rotator cuff / Medical device / Prosthesis / Medicine / Anatomy / Health


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Document Date: 2013-01-09 11:27:23

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File Size: 167,30 KB

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City

KWS / Warsaw / HSD / /

Company

Trabecular Metal / Zimmer Inc. / K122692 Trade / /

Country

United States / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

joint metal/polymer semi21 / announcements concerning your device / predicate devices / manufacturing practice requirements / reverse applications / cement / marketed predicate devices / joint metal/polymer / manufacturing practice / hemi-arthroplasty applications / manufacturing processes / /

MedicalCondition

traumatic disease / pain / fatigue / avascular necrosis / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Division of Orthopedic Devices16 / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Erin I1*eith Mark N. Melkerson Director Division / /

Person

Anthony Francalancia / Silver Spring / Anton E.Dmitriev / Mark N. Melkerson / /

/

Position

Specialist / Regulatory Affairs / humeral head / Senior Specialist / Regulatory Affairs / /

Product

Federal Food / /

ProvinceOrState

Maryland / Indiana / /

Technology

radiation / http / /

URL

www.fda.gov/MedicalDevices/ResourcesforYou/Industr/default.htm / www.fda.eov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm / http /

SocialTag