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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 K123890
Device Name ACUMED CANNULATED SCREW SYSTEM
Applicant
ACUMED LLC
5885 NW Cornelius Pass Rd
HILLSBORO,  OR  97124
Applicant Contact KARA BUDOR
Correspondent
ACUMED LLC
5885 NW Cornelius Pass Rd
HILLSBORO,  OR  97124
Correspondent Contact KARA BUDOR
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
OUR  
Date Received12/18/2012
Decision Date 03/18/2013
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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