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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K936045
Device Name ACE UNILATERAL FIXATOR II
Applicant
Ace Orthopedic Manufacturing Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Applicant Contact NANCY GIEZEN
Correspondent
Ace Orthopedic Manufacturing Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Correspondent Contact NANCY GIEZEN
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/20/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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