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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 K903810
Device Name ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
Applicant
Ace Medical Co.
C/O Buckman Co., Inc.
1000 Burnette Ave., Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Ace Medical Co.
C/O Buckman Co., Inc.
1000 Burnette Ave., Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/20/1990
Decision Date 10/16/1990
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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