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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K990120
Device Name MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
Applicant
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Applicant Contact KATHLEEN DRAGOVICH
Correspondent
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Correspondent Contact KATHLEEN DRAGOVICH
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/13/1999
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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