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Orthopedic surgery / Food and Drug Administration / Spinal fusion / Skeletal system / Vertebral fixation / Human vertebral column / Medical device / Spinal disc herniation / Spinal cord / Medicine / Vertebral column / Neurosurgery


Ki122630 Page 1 of 2 SpineSmith IN:C2 Spinal Fixation System 510(k) Summary of Safety and Effectiveness SUBMITTED BY
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Document Date: 2013-01-09 11:27:21

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File Size: 152,77 KB

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City

Austin / /

Company

Spine Smith Partners L.P. / SpineSmith Partners LLP / K122630 Trade / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

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IndustryTerm

Internet address http /

MedicalCondition

osteophyte / intractable radiculopathy / myelopathy / spinal cord compression / cervical disc disease / herniated disc / lordosis / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Mark N. Meikerson Director Division / Device Evaluation Center for Devices / Division of Orthopedic Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH's office of Surveillance / /

Person

Caroline Rhim / Silver Spring / Mark N. Meikerson / Clifton (Chris) Naivar / /

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Position

Director - Quality and Regulatory Affairs Phone / Director / Quality and Regulatory Affairs / /

Product

C2 Spinal Fixation System / C2 System / Federal Food / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / /

URL

www.fda.2zov/AboutFDA/CentersOffices/CDRH/CDRHiOffices/ucm / http /

SocialTag