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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K083144
Device Name ACUMED CLAVICLE SCREW SYSTEM
Applicant
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact ALYSSA THOMAS
Correspondent
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact ALYSSA THOMAS
Regulation Number888.3040
Classification Product Code
JDW  
Date Received10/23/2008
Decision Date 06/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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