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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K152256
Device Name RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and 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 Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/10/2015
Decision Date 11/05/2015
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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