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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K083567
Device Name GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
Applicant
Co-Ligne AG
1070 Conrad Ave., Suite 230
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Co-Ligne AG
1070 Conrad Ave., Suite 230
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received12/03/2008
Decision Date 09/14/2009
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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