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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 K020446
Device Name MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W
Minnetonka,  MN  55343
Applicant Contact ELSA A LINKE
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W
Minnetonka,  MN  55343
Correspondent Contact ELSA A LINKE
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
GAT  
Date Received02/11/2002
Decision Date 03/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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