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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 K131061
Device Name RESTORE BUNION CORRECTION SYSTEM
Applicant
Nextremity Solutions
54 Broad St., Suite 200
Red Bank,  NJ  07701
Applicant Contact JANET WEBB
Correspondent
Nextremity Solutions
54 Broad St., Suite 200
Red Bank,  NJ  07701
Correspondent Contact JANET WEBB
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HRS   HWC  
Date Received04/16/2013
Decision Date 08/28/2013
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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