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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K102549
Device Name THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
Applicant
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact SUSAN WALTON
Correspondent
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact SUSAN WALTON
Classification Product Code
LZJ  
Date Received09/07/2010
Decision Date 12/21/2010
Decision Substantially Equivalent (SESE)
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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