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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/polymer, porous uncemented
510(k) Number K033716
Device Name TRIDENT ACETABULAR SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact DENISE DUCHENE
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact DENISE DUCHENE
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LWJ   LZO   MEH  
Date Received11/26/2003
Decision Date 02/10/2005
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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