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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K912598
Device Name ACE CORTICAL BONE SCREW
Applicant
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Applicant Contact GLORIA TESKE
Correspondent
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Correspondent Contact GLORIA TESKE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/10/1991
Decision Date 11/27/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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