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


K20[removed]k) Summary of Safety and Effectiveness PAGEU -1f PERI-LOC Ankle Fusion Bone Plates, VLP 2.7mm Extra Large Percutaneous Calcaneus Plate Device Specific Instrument
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Document Date: 2012-05-28 00:35:04

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File Size: 186,27 KB

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City

Memphis / /

Company

K120667 Trade / Smith & Nephew Inc. / /

Event

FDA Phase / /

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IndustryTerm

announcements concerning your device / predicate devices / predicate device / grade stainless steel material / manufacturing practice requirements / marketed predicate devices / manufacturing practice / subject devices / device specific instrument devices / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / Melkerson Director Division of Surgical / 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 Premarket Notification Indications / /

Person

Silver Spring / David Henley / /

/

Position

Manager Tel / Regulatory Affairs Project Manager / /

Product

Federal Food / A1i / K1 / /

ProvinceOrState

Tennessee / /

Technology

radiation / /

URL

www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffie/ucm1 / http /

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