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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 K892214
Device Name REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
Applicant
Ace Medical Co.
David W. Schlerf
921 Calle Verde
Martinez,  CA  94553
Applicant Contact CO, INC.
Correspondent
Ace Medical Co.
David W. Schlerf
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact CO, INC.
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/03/1989
Decision Date 06/22/1989
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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