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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 K150851
Device Name Sure Lok Mini Posterior Cervical/Upper Thoracic System
Applicant
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact Michael Dawson
Correspondent
Empirical Consulting, LLC
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3050
Classification Product Code
KWP  
Date Received03/31/2015
Decision Date 06/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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