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Neurosurgery / Orthopedic surgery / Implants / Prosthetics / Vertebral fixation / Spondylolisthesis / Scoliosis / Degenerative disc disease / Back pain / Medicine / Vertebral column / Anatomy


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Document Date: 2013-01-09 11:27:46


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City

Interpace Parkway Parsippany / Parsippany / /

Company

Biomet / AKA EBI LLC / Interpace / K123451 Trade / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

subject device / noncervical spinal fixation device / announcements concerning your device / predicate devices / predicate device / fundamental technology / manufacturing practice requirements / spinal fixation device / non-cervical spinal fixation device / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

tumor / degenerative disc disease / deformity / kyphosis / spondylolisthesis / discogenic back pain / MS / scoliosis / lordosis / /

MedicalTreatment

spinal surgery / /

Organization

Division of Postmarket Surveillance / CDRH' s office of Surveillance / Division Sign-off Division of Orthopedic Devices / Center for Devices and Radiological Health / office of Compliance / Erin I.-Keith Mark N. Mdikerson Acting Director Division / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Surgical Devices Office / Food Public Health Service / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Drug Administration / /

Person

Silver Spring / Keith Mark / Vivian Kelly / /

/

Position

Manager Phone / Project Manager / surgeon / Regulatory Affairs Project Manager / /

Product

Federal Food / /

ProvinceOrState

New Jersey / Maryland / /

Technology

radiation / http / /

URL

www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm / www.fda.2ov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm / http /

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