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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K022985
Device Name ASCENDENT ACETABULAR SYSTEM
Applicant
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact FRANCES E HARRISON
Correspondent
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact FRANCES E HARRISON
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDJ   KWA   LWJ  
Date Received09/09/2002
Decision Date 12/05/2002
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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