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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K103797
Device Name K2M COCR WIRE
Applicant
K2m,Inc.
751 Miller Dr. SE
Leesburg,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2m,Inc.
751 Miller Dr. SE
Leesburg,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received12/27/2010
Decision Date 05/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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