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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 K030958
Device Name ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/27/2003
Decision Date 11/20/2003
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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