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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 K063244
Device Name ARC SURGICAL BONE REDUCTION SCREW
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
HWC  
Date Received10/26/2006
Decision Date 12/27/2006
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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