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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 K042871
Device Name TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
Applicant
ZIMMER TRABECULAR
80 COMMERCE DR.
ALLENDALE,  NJ  07401
Applicant Contact MARCI HALEVI
Correspondent
ZIMMER TRABECULAR
80 COMMERCE DR.
ALLENDALE,  NJ  07401
Correspondent Contact MARCI HALEVI
Regulation Number888.3358
Classification Product Code
LPH  
Date Received10/18/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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