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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 K043176
Device Name ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
Applicant
Arc Surgical, LLC
5885 NW Cornelius Pass Rd.
Suite 100
Hillsboro,  OR  97124
Applicant Contact ED BOEHMER
Correspondent
Arc Surgical, LLC
5885 NW Cornelius Pass Rd.
Suite 100
Hillsboro,  OR  97124
Correspondent Contact ED BOEHMER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/16/2004
Decision Date 06/17/2005
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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