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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, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K984498
Device Name SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3030
Classification Product Code
KTT  
Date Received12/17/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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