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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 K100176
Device Name ASCENSION ANKLE FUSION PLATE SYSTEM
Applicant
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754 -3832
Applicant Contact DEBBIE STEARNS
Correspondent
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754 -3832
Correspondent Contact DEBBIE STEARNS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/21/2010
Decision Date 06/16/2010
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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