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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K112025
Device Name SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
Applicant
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact FRANKIE CUMMINS
Correspondent
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Correspondent Contact FRANKIE CUMMINS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/15/2011
Decision Date 09/15/2011
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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