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Food law / Neurosurgery / Pharmaceuticals policy / Premarket approval / Medical device / Vertebral fixation / Center for Devices and Radiological Health / Federal Food / Drug / and Cosmetic Act / Spinal fusion / Medicine / Food and Drug Administration / Orthopedic surgery


K122733 Page 1 of[removed]k) Summary DEC
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Document Date: 2013-01-09 11:27:23

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File Size: 129,07 KB

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Company

K122733 Trade / /

Event

FDA Phase / /

Facility

Building F Austin / New Hampshire Avenue Document Control Center / /

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IndustryTerm

temporary supplemental fixation device / announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

Organization

Division of Pdstmarket Surveillance / Food and Drug Administration / Riata Park Court / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / office of Surveillance / Device Evaluation Center for Devices / *Mark N. Melkerson Mark N. Melkerson Director Division / Division of Orthopedic Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Orthopaedic Devices Office / /

Person

Caroline Rhim / Silver Spring / Mark N. Melkerson / Ron Yarbrough / Jennifer Tribbett / /

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Position

Director of Regulatory Affairs / surgeon / /

Product

Federal Food / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / http / /

URL

http /

SocialTag