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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 K123347
Device Name NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
Applicant
Normed Medizin-Technik GmbH
8708 Capehart Cove
Austin,  TX  78733
Applicant Contact DAVID C FURR
Correspondent
Normed Medizin-Technik GmbH
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DAVID C FURR
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received10/31/2012
Decision Date 08/02/2013
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
Recalls CDRH Recalls
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