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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 K915672
Device Name EDWARDS ADJUSTABLE CONNECTORS
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 Received12/17/1991
Decision Date 05/26/1993
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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