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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 K080075
Device Name MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
Applicant
Elite Surgical Supplies (Pty), Ltd.
503 Commerce Park Dr.
Suite 1
Marietta,  GA  30060
Applicant Contact CHARISE DE BARROS
Correspondent
Elite Surgical Supplies (Pty), Ltd.
503 Commerce Park Dr.
Suite 1
Marietta,  GA  30060
Correspondent Contact CHARISE DE BARROS
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received01/11/2008
Decision Date 01/28/2008
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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