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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 -3832
Applicant Contact PETER STRZEPA
Correspondent
ASCENSION ORTHOPEDICS, INC.
8200 CAMERON RD., SUITE C-140
AUSTIN,  TX  78754 -3832
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
Recalls CDRH Recalls
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