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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, Metal Composite
510(k) Number K031973
Device Name SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
Applicant
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact BONNIE J SMITH
Correspondent
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact BONNIE J SMITH
Regulation Number888.3030
Classification Product Code
LXT  
Date Received06/26/2003
Decision Date 09/05/2003
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
Recalls CDRH Recalls
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