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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K050101
Device Name THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
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 Number888.3030
Classification Product Code
HRS  
Date Received01/18/2005
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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