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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 K032604
Device Name GII SPINAL FIXATION SYSTEM
Applicant
Co-Ligne AG
9260 Viau Blvd.
Montreal,  CA H1R 2V8
Applicant Contact ARIEL DUJOVNE, ING. M.SC.
Correspondent
Co-Ligne AG
9260 Viau Blvd.
Montreal,  CA H1R 2V8
Correspondent Contact ARIEL DUJOVNE, ING. M.SC.
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received08/25/2003
Decision Date 01/20/2004
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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