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Implants / Neurosurgery / Skeletal system / Vertebral fixation / Spondylolisthesis / Scoliosis / Degenerative disc disease / Polyaxial screw / Kyphosis / Medicine / Orthopedic surgery / Vertebral column


510(k) Summary: REVIERE Additional Implants Company: Contact: Globus Medical Inc.
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Document Date: 2012-11-09 20:53:33

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City

Audubon / /

Company

REVIERE Additional Implants Company / Synthes / Staples / DePuy / Globus Medical Inc. / K122226 Trade / /

Event

FDA Phase / /

IndustryTerm

treatment of degenerative disc disease / stainless steel / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / Internet address http /

MedicalCondition

spinal stenosis / deformities / tumor / degenerative disc disease / severe spondylolisthesis / spinal tumor / kyphosis / spondylolisthesis / i.e. scoliosis / discogenic back pain / spinal deformities / degenerative spondylolisthesis / Scheuermann's disease / scoliosis / lordosis / acute and chronic instabilities / /

OperatingSystem

L3 / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Divi Signof Division of Surgical / CDRH 's office of Surveillance / FDA / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use Statement / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Mark N. Melkerson Director Division of Surgical / /

Person

Meriamn Youssef / Silver Spring / Mark N. Melkerson / /

/

Position

Project Manager / Regulatory Affairs / Manager / Regulatory Affairs ocr / /

Product

Federal Food / REVERE® Stabilization System Classification / REVERE® / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / http / /

URL

http /

SocialTag