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Neurosurgery / Implants / Synthes / Vertebral fixation / Spondylolisthesis / Scoliosis / Degenerative disc disease / Medical device / TRS connector / Medicine / Vertebral column / Orthopedic surgery


Document Date: 2012-03-26 00:31:10

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City

Chester / /

Company

K 113149 Trade / Synthes / /

Currency

USD / /

Event

FDA Phase / /

IndustryTerm

non-cervical spinal fixation devices / announcements concerning your device / predicate devices / rod systems / manufacturing practice requirements / Internet address http /

Movie

X / Click / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / Device Evaluation Center for Devices and Radiological Health Enclosure @SYAFFES6 Spine Indications for Use Statement / office of Device Evaluation / Department of Defense / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / CDRH's office of Surveillance / Division of Surgical / /

Person

Silver Spring / Mark N. Mel / Heather Guerin / /

/

Position

ersonl Director / Spine Senior Regulatory Affairs Specialist / /

Product

K1 00634 Synthes Matrix System / K092929 Synthes Matrix System / Food / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / /

URL

http /

SocialTag