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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 K061067
Device Name TRABECULAR METAL ACETABULAR AUGMENTS
Applicant
ZIMMER TRABECULAR
80 COMMERCE DR.
ALLENDALE,  NJ  07401
Applicant Contact ROBERT A POGGIE
Correspondent
ZIMMER TRABECULAR
80 COMMERCE DR.
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT A POGGIE
Regulation Number888.3358
Classification Product Code
LPH  
Date Received04/17/2006
Decision Date 05/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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