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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 K896740
Device Name AXIAL AND OFFSET CROSSLINK PLATES
Applicant
DANEK MEDICAL, INC.
3092 DIRECTOR'S ROW
MEMPHIS,  TN  38131
Applicant Contact FRANK M LEWIS
Correspondent
DANEK MEDICAL, INC.
3092 DIRECTOR'S ROW
MEMPHIS,  TN  38131
Correspondent Contact FRANK M LEWIS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/30/1989
Decision Date 02/26/1990
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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