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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 K990848
Device Name TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
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  
Date Received03/15/1999
Decision Date 05/17/1999
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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