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Vertebral column / Food and Drug Administration / Food law / Discectomy / Spondylolisthesis / Degenerative disc disease / Vertebral fixation / Federal Food /  Drug /  and Cosmetic Act / Medical device / Medicine / Neurosurgery / Orthopedic surgery


Pa4 e /0o1, O(SOOE7- FEB[removed]k) SUMMARY
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Document Date: 2013-03-08 15:16:21


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File Size: 157,13 KB

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City

Northwest Washington / /

Company

NIT Spine Limited / Lovells US LLP / K130057 Trade / NLT SPINE Ltd. / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Documnent Control Center / /

/

IndustryTerm

announcements concerning your device / predicate device / rod systems / manufacturing practice requirements / Internet address htto /

MedicalCondition

degenerative disc disease / back pain / I Spondylolisthesis / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / New Hampshire Avenue Documnent Control Center / office of Device Evaluation / Mark N. Melkerson Acting Director Division / Surgical Devices Office / Department of Defense / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Surgical Devices / CDRH's office of Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Page / /

Person

John Smith / Silver Spring / /

/

Position

Director NLT SPINE Ltd. Regulatory Affairs / Eti Ziniger Regulatory Affairs Director / Physician / /

Product

Federal Food / /

ProvinceOrState

District of Columbia / Maryland / /

Region

Northwest Washington / /

Technology

radiation / X-ray / /

URL

http /

SocialTag