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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K131920
Device Name STABILIZATION SCREW
Applicant
IN2BONES SAS
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN, PH.D.
Correspondent
IN2BONES SAS
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN, PH.D.
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/26/2013
Decision Date 05/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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