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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 K984357
Device Name TRANSFX EXTERNAL FIXATION SYSTEM
Applicant
IMMEDICA, INC.
100 PASSAIC AVE.
CHATHAM,  NJ  07928 -2848
Applicant Contact ROY BOGERT
Correspondent
IMMEDICA, INC.
100 PASSAIC AVE.
CHATHAM,  NJ  07928 -2848
Correspondent Contact ROY BOGERT
Regulation Number888.3030
Classification Product Code
LXT  
Subsequent Product Codes
JDW   KTT  
Date Received12/07/1998
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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