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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K051764
Device Name T-PLATE ANTERIOR FIXATION SYSTEM
Applicant
Esm Technologies
403 Farwell Dr.
Madison,  WI  53704
Applicant Contact CLIFF TRIBUS
Correspondent
Esm Technologies
403 Farwell Dr.
Madison,  WI  53704
Correspondent Contact CLIFF TRIBUS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/30/2005
Decision Date 07/13/2005
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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