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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K031438
Device Name ACUMED SMALL BONE LOCKING ROD SYSTEM II
Applicant
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact ED BOEHMER
Correspondent
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact ED BOEHMER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/06/2003
Decision Date 07/17/2003
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
Recalls CDRH Recalls
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