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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 K151708
Device Name RECON system - Compression Screws
Applicant
Normed Medizin-Technik GmbH
Ulrichstrasse 7
Tuttlingen,  DE D-78532
Applicant Contact ARNE BRIEST
Correspondent
Normed Medizin-Technik GmbH
Ulrichstrasse 7
Tuttlingen,  DE D-78532
Correspondent Contact ARNE BRIEST
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received06/24/2015
Decision Date 03/02/2016
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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