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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, Smooth
510(k) Number K071616
Device Name ARC SURGICAL BIOTRAK PIN SYSTEM
Applicant
Arc Surgical, LLC
21300 NW Jacobson Rd.
Hillsboro,  OR  97124
Applicant Contact ED BOEHMER
Correspondent
Arc Surgical, LLC
21300 NW Jacobson Rd.
Hillsboro,  OR  97124
Correspondent Contact ED BOEHMER
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/13/2007
Decision Date 12/19/2007
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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