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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K043061
Device Name THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
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 Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
KWT  
Date Received11/05/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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