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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 K063616
Device Name TRIDENT II ACETABULAR SYSTEM
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact MANAL MORCOS
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact MANAL MORCOS
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/05/2006
Decision Date 12/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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