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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 K914269
Device Name EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO
Applicant
Scientific Spinal , Ltd.
School Of Medicine
Deptment Of Surgery
Baltimore,  MD  21201
Applicant Contact CHARLES C EDWARDS
Correspondent
Scientific Spinal , Ltd.
School Of Medicine
Deptment Of Surgery
Baltimore,  MD  21201
Correspondent Contact CHARLES C EDWARDS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/24/1991
Decision Date 12/18/1991
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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