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


t Em )02z9 510(k) Summary: CALIBER TM Spacer Company:
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Document Date: 2011-02-17 14:36:11

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File Size: 141,37 KB

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City

Audubon / /

Company

CALIBER TM Spacer Company / REVOLVE TM Stabilization Systems / K102293 Trade / REVOLVETM Stabilization Systems / Globus Medical Inc. / Ph.D / /

IndustryTerm

announcements concerning your device / body fusion device / interbody fusion devices / manufacturing practice requirements / predicate systems / lumbar interbody fusion devices / marketed predicate devices / Internet address lhttp /

MedicalCondition

degenerative disc disease / spondylolisthesis / discogenic back pain / /

Organization

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

Person

Silver Spring / Kelly J. Baker / Mark N. Melkerson / /

/

Position

Director / Clinical Affairs & Regulatory Date Prepared / /

Product

Spacers / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / /

URL

http /

SocialTag