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Food law / Neurosurgery / Orthopedic surgery / Spinal fusion / Vertebral column / Medical device / Degenerative disc disease / Premarket approval / Lordosis / Medicine / Health / Food and Drug Administration


K1[removed]Page 1 of[removed]k) Summary Maxim Surgical X-Treme Interbody Fusion System Premarket Notification
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Document Date: 2013-03-08 15:18:15


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File Size: 156,54 KB

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City

Richardson / /

Company

K123206 Trade / /

Currency

pence / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / North Central Expressway / /

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IndustryTerm

treatment of degenerative disc disease / cervical intervertebral body fusion device / cleared interbody fusion systems / announcements concerning your device / predicate devices / manufacturing practice requirenments / body fusion device / stainless steel materials / predicate device / Internet address http /

MedicalCondition

degenerative disc disease / pain / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Device Evaluation Center for Devices and Radiological Health Enclosure Pagelofi1 / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Public Health Service / Mark N.Melkerson Mark N. Melkerson Director Division / Division of Orthopedic Devices / Department of Defense / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Drug Administration / /

Person

Chris Reeg / Mark N. Melkerson / Lisa Peterson / /

/

Position

President / surgeon / /

Product

Federal Food / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / /

URL

www.fda / www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm / http /

SocialTag