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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K113364
Device Name 2.7MM LCP ULNA OSTEOTOMY SYSTEM
Applicant
SYNTHES (USA) PRODUCTS LLC
1230 Wilson Dr
West Chester,  PA  19380
Applicant Contact REBECCA BLANK
Correspondent
SYNTHES (USA) PRODUCTS LLC
1230 Wilson Dr
West Chester,  PA  19380
Correspondent Contact REBECCA BLANK
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/15/2011
Decision Date 02/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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