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Orthopedic surgery / Implants / Prosthetics / Vertebral fixation / Spondylolisthesis / Degenerative disc disease / Human vertebral column / Medical device / Spinal stenosis / Medicine / Vertebral column / Neurosurgery


510(k) SUMMARY8607 Lanx Spinal Fixation System 27 Submitter Information
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Document Date: 2012-10-09 13:29:16


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File Size: 184,08 KB

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City

Broomfield / /

Company

Lanx Inc. / BridgePoint / Nuvasive / K121316 Trade / Alphatec / /

IndustryTerm

Internet address http /

MedicalCondition

deformities / spinal stenosis / tumor / degenerative disc disease / shear fatigue / kyphosis / spondylolisthesis / i.e. scoliosis / back pain / lordosis / /

Organization

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

Person

Silver Spring / William Sandul / Will Sandul / /

/

Position

Director of Engineering / Director / surgeon / /

ProvinceOrState

Maryland / Colorado / /

Technology

radiation / fundamental scientific technology / /

URL

http /

SocialTag