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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K141397
Device Name SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
Applicant
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact MICHAEL C DAWSON
Correspondent
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Correspondent Contact MICHAEL C DAWSON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received05/28/2014
Decision Date 06/26/2014
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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