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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K151160
Device Name Arcus Staple System
Applicant
Nextremity Solutions, Inc.
54 Broad St., Suite 200
Red Bank,  NJ  07701
Applicant Contact Ryan Schlotterback
Correspondent
Nextremity Solutions, Inc.
54 Broad St., Suite 200
Red Bank,  NJ  07701
Correspondent Contact Ryan Schlotterback
Regulation Number888.3030
Classification Product Code
JDR  
Date Received05/01/2015
Decision Date 09/04/2015
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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