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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 Intervertebral Body
510(k) Number K063764
Device Name SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM
Applicant
Southern Spine, LLC
111 Laurel Ridge Dr.
Alpharetta,  GA  31201
Applicant Contact JULIE STEPHENS
Correspondent
Southern Spine, LLC
111 Laurel Ridge Dr.
Alpharetta,  GA  31201
Correspondent Contact JULIE STEPHENS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/20/2006
Decision Date 05/16/2007
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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