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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 K111799
Device Name NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
Applicant
ASCENSION ORTHOPEDIC
8700 CAMERON RD., STE. 100
Austin,  TX  78754
Applicant Contact BRADLEY W STRASSER
Correspondent
ASCENSION ORTHOPEDIC
8700 CAMERON RD., STE. 100
Austin,  TX  78754
Correspondent Contact BRADLEY W STRASSER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/27/2011
Decision Date 08/19/2011
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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