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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Trapezium
510(k) Number K112278
Device Name ASCENSION NUGRIP CMC IMPLANT
Applicant
Ascension Orthopedic
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact BRADLEY W STRASSER
Correspondent
Ascension Orthopedic
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact BRADLEY W STRASSER
Regulation Number888.3770
Classification Product Code
KYI  
Date Received08/09/2011
Decision Date 11/04/2011
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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