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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 K021970
Device Name THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Applicant Contact ROBERT A POGGIE
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Correspondent Contact ROBERT A POGGIE
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received06/17/2002
Decision Date 07/12/2002
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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