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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 K143229
Device Name Nexis osteosynthesis compressive screws
Applicant
NOVASTEP
Espace performance Alphasis - Batiment C1-C2
Saint Gregoire,  FR 35769
Applicant Contact Gilles Audic
Correspondent
NOVASTEP
Espace performance Alphasis - Batiment C1-C2
Saint Gregoire,  FR 35769
Correspondent Contact Gilles Audic
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/10/2014
Decision Date 02/06/2015
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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