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Neurosurgery / Human vertebral column / Skeletal system / Biomet / Bone fracture / Cervical vertebrae / Medical device / Spinal fusion / Vertebral fixation / Medicine / Traumatology / Orthopedic surgery


K123906-Page 1 of 3 VERTEX® Reconstruction System AR021
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Document Date: 2013-05-06 11:19:47

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File Size: 195,91 KB

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City

Pyramid Place Memphis / /

Company

VERTEX / K123906 Trade / Medtronic Sofamor Danek USA Incorporated / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / Pyramid Place Memphis / /

/

IndustryTerm

stainless steel / announcements concerning your device / predicate devices / manufacturing practice requirements / Internet address http /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / DEPARTMENT OF HEALTHI / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices / Division of Orthopedic Devices / Division of Small Manufacturers / International and Consumer Assistance / New Hampshire Avenue Document Control Center / Mark N. Melkerson Director Division / CDRH's office of Surveillance / Center for Devices / /

Person

Ronald P.Jean / Claire Evans / Mark N. Melkerson / /

/

Position

surgeon / Senior Regulatory Affairs Specialist / /

Product

Federal Food / /

ProvinceOrState

Tennessee / Maryland / /

Technology

design verification / radiation / /

URL

http /

SocialTag