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


510(K) Summary: REVLOK Tm Fenestrated Screw System Company: Contact: Globus Medical Inc.
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Document Date: 2011-08-29 00:29:54


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City

Audubon / /

Company

Stabilization Systems / K1 10280 Trade / Globus Medical Inc. / REVLOK Tm Fenestrated Screw System Company / D. / Ph.D / /

Event

FDA Phase / /

IndustryTerm

Internet address htp/wwfagvcr/nutyspo-/ne~tl Sincerely / stainless steel / announcements concerning your device / predicate device / bone cement / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /

MedicalCondition

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

OperatingSystem

L3 / /

Organization

Division of Postmarket Surveillance / office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration Enclosure Indications for Use Statement Kiloso / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / office of Surveillance / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /

Person

Silver Spring / Christy Foreman / Kelly J. Baker / /

/

Position

Vice President / Regulatory and Clinical Affairs / Director / Vice President / Regulatory & Clinical Affairs JUL / Ph. Vice President / Regulatory and Clinical Affairs / Vice President / Regulatory & Clinical Affairs / /

Product

REVEREĀ® / 2I1CFR / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / /

URL

www.fda.gov/cdrh/mndr / /

SocialTag