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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 K003823
Device Name SCS DT-02 TRANSVERSE CONNECTOR
Applicant
Ortho Tec, LLC
546 Hillgreen Dr.
Beverly Hills,  CA  90212
Applicant Contact PATRICK BERTRANOU
Correspondent
Ortho Tec, LLC
546 Hillgreen Dr.
Beverly Hills,  CA  90212
Correspondent Contact PATRICK BERTRANOU
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/11/2000
Decision Date 07/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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