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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 K031452
Device Name ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
Applicant
Ortho Tec, LLC
9595 Wilshire Blvd., Suite 502
California,  CA  90212
Applicant Contact PATRICK BERTRANOU
Correspondent
Ortho Tec, LLC
9595 Wilshire Blvd., Suite 502
California,  CA  90212
Correspondent Contact PATRICK BERTRANOU
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received05/07/2003
Decision Date 06/18/2003
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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