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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 K061451
Device Name ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
Applicant
ASCENSION ORTHOPEDICS, INC.
8700 CAMERON RD., STE. 100
AUSTIN,  TX  78754 -3832
Applicant Contact GLEN NEALLY
Correspondent
ASCENSION ORTHOPEDICS, INC.
8700 CAMERON RD., STE. 100
AUSTIN,  TX  78754 -3832
Correspondent Contact GLEN NEALLY
Regulation Number888.3770
Classification Product Code
KYI  
Date Received05/25/2006
Decision Date 08/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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