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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 K140962
Device Name NORMED VARIO SUBTALAR SCREW
Applicant
Normed Nedizin Technik GmbH
8708 Capehart Cove
Austin,  TX  78733
Applicant Contact DAVID FURR
Correspondent
Normed Nedizin Technik GmbH
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DAVID FURR
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/15/2014
Decision Date 07/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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