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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
Original Applicant
SULZER ORTHOPEDICS, INC.
9900 spectrum dr.
austin,  TX  78717
Original 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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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