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Neurosurgery / Orthopedic surgery / Spondylolisthesis / Vertebral fixation / Scoliosis / Human vertebral column / Degenerative disc disease / Kyphosis / Biomet / Medicine / Anatomy / Vertebral column


k10 3?I13 SPINE 510(k) Summary
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Document Date: 2011-03-07 11:37:17


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File Size: 195,65 KB

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City

Interpace Parkway Parsippany / /

Company

Biomet / /

Event

FDA Phase / /

/

IndustryTerm

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

MedicalCondition

tumor / degenerative disc disease / Fatigue / deformity / kyphosis / spondylolisthesis / discogenic back pain / dynamic compression bending fatigue / scoliosis / lordosis / /

MedicalTreatment

spinal surgery / /

Organization

Orthopedic And Restorative Devices Office / Division of Postmarket 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 / FDA / CDRIl's office of Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division of Surgical / /

Person

Vivian Kelly / Mark N. Melkerson / /

/

Position

surgeon / /

Product

Federal Food / /

ProvinceOrState

New Jersey / /

Technology

radiation / /

URL

http /

SocialTag