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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K143350
Device Name Nile Alternative Fixation
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
OWI  
Date Received11/24/2014
Decision Date 02/25/2015
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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