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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(k) Number K033943
Device Name ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
Applicant
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact AUDREY SWEARINGEN
Correspondent
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact AUDREY SWEARINGEN
Regulation Number888.3330
Classification Product Code
KWA  
Date Received12/19/2003
Decision Date 10/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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