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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 K011034
FOIA Releasable 510(k) K011034
Device Name SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Applicant Contact BONNIE J SMITH
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Correspondent Contact BONNIE J SMITH
Regulation Number888.3030
Classification Product Code
KTT  
Date Received04/05/2001
Decision Date 06/27/2001
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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