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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K124014
Device Name SUREFIX INTERSPINOUS FUSION SYSTEM
Applicant
Jg Spine, LLC
100 E. S. Main St.
Waxhaw,  NC  28173
Applicant Contact JOHN KAPITAN
Correspondent
Jg Spine, LLC
100 E. S. Main St.
Waxhaw,  NC  28173
Correspondent Contact JOHN KAPITAN
Regulation Number888.3050
Classification Product Code
PEK  
Date Received12/27/2012
Decision Date 08/09/2013
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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