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Orthopedic surgery / Implants / Prosthetics / Vertebral fixation / Degenerative disc disease / Human vertebral column / Medical device / Spondylolisthesis / Back pain / Medicine / Vertebral column / Neurosurgery


APR - 7 NOYr1 510(k) Summary Submitted By: Establishment
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Document Date: 2011-05-30 00:44:55

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File Size: 171,21 KB

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City

Washington / Brisbane / /

Company

CoAlign Invations Inc. / Musculloskeictal Clinical Regulatory Advisors LLC / K110270 Trade / CoAlign Innovations Inc. / Clinical & Regulatory Advisers LLC / /

Event

FDA Phase / /

IndustryTerm

stainless steel / announcements concerning your device / predicate devices / body fusion device / manufacturing practice requirements / Internet address htp/wwfagvMdcieie/eoics'ro/nLsr/eaithm Sincerely / marketed predicate devices / manufacturing practice / /

MedicalCondition

tumor / degenerative disc disease / back pain / I spondylolisthesis / /

Organization

Food and Drug Administration / office of Compliance / office of Device Evaluation / Department of Defense / Division of Small Manufacturers / International and Consumer Assistance / CDRH's office of Surveillance and Biometrics/Di / U.S. Securities and Exchange Commission / Surgical / Orthopedic and Restorative Devices Office / 2DEPARTMENT Public Health Service OF HEALTH / Mark N. Melkerson Director Division of Surgical / Center for Devices / Center for Devices and Radiological Flealth / /

Person

Justin Eggleton / Mark N. Melkerson / /

/

Product

AccuLIF Cage / Federal Food / /

ProgrammingLanguage

DC / /

ProvinceOrState

District of Columbia / Maryland / Washington / California / /

Region

Northwest / /

Technology

radiation / /

URL

http /

SocialTag