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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K100925
Device Name ASCENSION ANKLE FUSION NAIL SYSTEM
Applicant
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact DEBBIE STEARNS
Correspondent
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact DEBBIE STEARNS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/02/2010
Decision Date 07/12/2010
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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