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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 K904243
Device Name TSRH VARIABLE ANGLE SACRAL SCREW
Applicant
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Applicant Contact FRANK LEWIS
Correspondent
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Correspondent Contact FRANK LEWIS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/14/1990
Decision Date 01/22/1992
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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