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Medical technology / Food and Drug Administration / Food law / Kirschner wire / Biomet / Medical device / Bone fracture / Federal Food / Drug / and Cosmetic Act / Premarket approval / Medicine / Orthopedic surgery / Implants


Pg[removed]a ImtK140216 10medicalMAY 01J2014
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Document Date: 2014-06-06 11:54:25

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File Size: 134,71 KB

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City

Suite B6 Portland / /

Company

LLW Orthopedic Fixation Systems / Orthopedic Fixation Systems / The Impact Medical LLC / Testing Impact Medical LLC / K1402l6 Trade / Substantial Equivalence Comparison Impact Medical LLC / /

Event

FDA Phase / /

Facility

Molybdenum Stainless Steel Bar / Adminisnaion I1D903 New HaImpshire Avenue Document Control Center / /

/

IndustryTerm

facility protocol / 316L stainless steel / announcements concerning your device / Internet address lhttp /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Food Drug and Adminisnaion I1D903 New HaImpshire Avenue Document Control Center / Division of Industry and Consumer Education / office of Device Evaluation / FDA / Device Evaluation Center for Devices / CDRH's office of Surveillance / /

Person

Lori A.Wiggins / Mark N. Melkerson / E.J. Duffy / /

/

Position

President / Chief Executive Officer / Director Division / /

Product

Orthopedic Fixation System / Federal Food / 2I1CFR / /

ProvinceOrState

Oregon / /

Technology

radiation / facility protocol / /

URL

www.fda.u~ov/Medical / http /

SocialTag