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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 K874670
Device Name ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
Applicant
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/13/1987
Decision Date 12/17/1987
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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