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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 K041451
Device Name ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
Applicant
Ascension Orthopedics, Inc.
8200 Cameron Rd., Suite C-140
Austin,  TX  78754
Applicant Contact PETER STRZEPA
Correspondent
Ascension Orthopedics, Inc.
8200 Cameron Rd., Suite C-140
Austin,  TX  78754
Correspondent Contact PETER STRZEPA
Regulation Number888.3770
Classification Product Code
KYI  
Date Received06/01/2004
Decision Date 08/25/2004
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
Recalls CDRH Recalls
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