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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 K080991
Device Name DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact DAWN SINCLAIR
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact DAWN SINCLAIR
Regulation Number888.3330
Classification Product Code
KWA  
Date Received04/07/2008
Decision Date 07/02/2008
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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