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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 K930807
Device Name SENTRY ANTERIOR SPINAL SYSTEM
Applicant
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Applicant Contact RICHARD TREHARNE
Correspondent
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Correspondent Contact RICHARD TREHARNE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/16/1993
Decision Date 10/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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