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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 K123093
Device Name STABILINK MIS SPINAL FIXATION 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 Number888.3050
Classification Product Code
KWP  
Date Received10/02/2012
Decision Date 12/20/2012
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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