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External fixation / Limb lengthening methods / Nonunion / Medical device / Premarket approval / Bone fracture / Title 21 of the Code of Federal Regulations / Food and Drug Administration / Medicine / Orthopedic surgery / Distraction osteogenesis


Document Date: 2013-06-10 14:13:17

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City

Corporate Drive Mahwah / /

Company

Smith and Nephew / Stryker Trauma AG / K130334 Trade / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

announcements concerning your device / predicate devices / manufacturing practice requirements / external fixation device / external fixation systems / Internet address http /

MedicalCondition

disease / joint contractures / soft tissue deformity / deformity / Closed Fractures Post-traumatic joint contracture / /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / office of Device Evaluation / aiRh& Division / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Mark N. Melkerson Director Division / CDRH4's office of Surveillance / /

Person

Silver Spring / Mark N. Melkerson / Estela Celi / /

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Position

Regulatory Affairs Specialist / /

ProvinceOrState

New Jersey / Maryland / /

Technology

radiation / MRI / /

URL

http /

SocialTag