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Food law / Medical equipment / Medical device / Medical technology / Federal Food / Drug / and Cosmetic Act / Premarket approval / Spondylolisthesis / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration


K IISCHZ FEB[removed]PERIMETER® Interhody Fusion Device 510(k) Summary
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Document Date: 2012-03-26 00:31:44

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File Size: 197,49 KB

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City

Pyramid Place Memphis / /

Company

Medtronic / K 13642 Trade / /

Event

FDA Phase / /

Facility

Pyramid Place Memphis / /

/

IndustryTerm

health care products / announcements concerning your device / medical devices / body fusion device / manufacturing practice requirements / re-sterilizable medical devices / resterilizable medical devices / Internet address http /

MedicalCondition

degenerative disc disease / sterility / discogenic back pain / I Spondylolisthesis / lordosis / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Device Evaluation Center for Devices and Radiological Health Enclosure / Mark N. Melkerson Director Division of Surgical / /

Person

Silver Spring / Lauren E. Kamter / Mark N. Melkerson / Lauren E. Kamer / /

/

Position

Senior Regulatory Affairs Specialist / /

Product

Federal Food / 2I1CFR / /

ProvinceOrState

Tennessee / Maryland / /

Technology

radiation / fundamental scientific technology / same fundamental scientific technology / /

URL

http /

SocialTag