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Implants / Medical technology / Medical equipment / Food and Drug Administration / Medical device / Premarket approval / Hip dysplasia / Federal Food / Drug / and Cosmetic Act / Prosthesis / Medicine / Health / Prosthetics


K140915 page 1 of 3 Special 510(k) Premarket Notification Aesculap Implant Systems Excia Total Hip System - Excia T JUL[removed]
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Document Date: 2014-08-08 12:37:32

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File Size: 142,79 KB

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City

Valley / /

Company

K140915 Trade / aesculaD.com TRADE / One Is / Aesculap Implant Systems LLC / /

Currency

USD / /

Event

FDA Phase / /

Facility

Corporate Parkway Center / /

IndustryTerm

subject device / announcements concerning your device / predicate devices / manufacturing practice requirements / joint metal/ceramic/polymer / marketed predicate devices / manufacturing practice / metal polymer / /

MedicalCondition

traumatic arthritis / congenital hip dysplasia / rheumatoid arthritis / polyarthritis / hip pain / osteoarthritis / collagen disorders / avascular necrosis / /

Organization

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

Person

Elizabeth L.Frank / Julie Tom Wing / Lori A.Wiggins / Mark N. Melkerson / /

/

Position

femoral head / Regulatory Affairs Specialist / /

Product

Federal Food / Excia T / /

ProvinceOrState

Pennsylvania / /

Technology

radiation / /

SocialTag