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NOV[removed]k) Summary In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR[removed], ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 51 0(k) Num
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Document Date: 2011-12-26 00:34:59


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File Size: 146,10 KB

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City

Concept Boulevard Largo / Largo / /

Company

ConMed Linvatec Inc. / KI 112965 Trade / /

Event

FDA Phase / /

IndustryTerm

Internet address hittp /

MedicalTreatment

orthopedic surgical procedures / orthopedic procedures / /

Organization

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

Person

Silver Spring / Ashlea Ricci / /

/

Position

driver / RAC Regulatory Affairs Specialist / Martke kerson Director / surgeon / /

Product

Federal Food / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

radiation / /

URL

www.fda.gov/MedicalDevices/Safety / www.fda.gov/MedicalDevices/Resour-cesforYou/IndiistrYefauLlt.hitn / http /

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