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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K022377
Device Name THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
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 Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
KWS  
Date Received07/22/2002
Decision Date 12/10/2002
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
Recalls CDRH Recalls
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