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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 Interlaminal
510(k) Number K936294
Device Name SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
Applicant
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH  
Date Received12/10/1993
Decision Date 12/19/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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