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Food and Drug Administration / Spondylolisthesis / Neurosurgery / Kyphosis / Federal Food / Drug / and Cosmetic Act / Medical device / Premarket approval / Degenerative disc disease / Back pain / Medicine / Health / Vertebral column


K113 625 Page 1 ot[removed]k) Summary
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Document Date: 2012-02-27 00:32:05

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File Size: 178,22 KB

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City

Washington / New York / /

Company

oMusculoskeletal Clinical Regulatory Advisers LLC / Paradigm Spine LLC / K1 13625 Trade / /

/

IndustryTerm

announcements concerning your device / manufacturing practice requirements / Internet address http /

MedicalCondition

deformities / spinal stenosis / tumor / degenerative disc disease / kyphosis / spondylolisthesis / degenerative spondylolisthesis / back pain / scoliosis / acute and chronic instabilities / lordosis / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation Center for Devices and Radiological Health Enclosure Page / office of Device Evaluation / office of Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /

Person

Christy Foreman / Michelle McDonough / Michelle McDonough Musculoskeletal / /

/

Position

Director / operating surgeon / /

ProgrammingLanguage

DC / /

ProvinceOrState

District of Columbia / Maryland / New York / /

Technology

radiation / fundamental scientific technology / /

URL

http /

SocialTag