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Neurosurgery / Implants / Spinal fusion / Vertebral fixation / Spondylolisthesis / Scoliosis / Human vertebral column / Degenerative disc disease / Kyphosis / Medicine / Vertebral column / Orthopedic surgery


Microsoft Word[removed]Tradi 510(k)_PSR_DR.docx
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Document Date: 2014-12-08 09:05:49

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File Size: 1,00 MB

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City

Lyon / /

Company

K123138 PASS LP / Spinal Systems / K140738 Trade / Number (if known) K140738 Device Name PASS LP / The PASS LP / Lumbar Design Diameters Lengths Curvatures Unknown PASS LP / Use (Describe) The PASS LP / 1 PSC Publishing / /

Country

France / /

Currency

USD / /

/

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

deformities / Spinal stenosis / tumor / extreme lordosis / degenerative disc disease / severe spondylolisthesis / tumors / extreme kyphosis / adolescent idiopathic scoliosis / kyphosis / spondylolisthesis / Degenerative spondylolisthesis / back pain / scoliosis / lordosis / acute and chronic instabilities / /

MedicalTreatment

surgery / /

OperatingSystem

L3 / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / Mark N. Melkerson Director Division / CDRH’s office of Surveillance / /

Person

Silver Spring / Mark N. Melkerson / David N. Ryan / /

/

Position

Director Marketing & Product Development 14 Porte du Grand Lyon Neyron / surgeon / /

Product

Spinal System / /

ProvinceOrState

Maryland / /

Technology

radiation / /

URL

http /

SocialTag