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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
Recalls CDRH Recalls
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