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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K840954
Device Name DYNAMIC CONDYLAR SCREW OR D.C.S.
Applicant
Synthes (Usa)
MD 
Correspondent
Synthes (Usa)
MD 
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/05/1984
Decision Date 05/11/1984
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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