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Food law / Orthopedic surgery / Vertebral column / Medical device / Spinal fusion / Federal Food /  Drug /  and Cosmetic Act / Degenerative disc disease / Premarket approval / Vertebral fixation / Medicine / Food and Drug Administration / Neurosurgery


10837 Pine Bluff · Fishers, IN 46038 · Tel: [removed]
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Document Date: 2014-10-06 09:57:09


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File Size: 79,42 KB

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City

Hoffman Estates / /

Company

K133717 Trade / Life Spine Incorporated / 1 PSC Publishing / /

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Facility

New Hampshire Avenue Document Control Center / /

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IndustryTerm

announcements concerning your device / intervertebral body fusion device / body fusion device / manufacturing practice requirements / predicate systems / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

degenerative disc disease / spondylolisthesis / back pain / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / Mark N. Melkerson Director Division / CDRH’s office of Surveillance / /

Person

Silver Spring / Mark N. Melkerson / Randy Lewis / /

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Position

Director / RA/QA / /

ProvinceOrState

Maryland / Illinois / /

Technology

radiation / /

URL

http /

SocialTag