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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 K023378
Device Name ORIA CLARIS
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
MNH  
Subsequent Product Code
MNI  
Date Received10/08/2002
Decision Date 06/27/2003
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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