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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 K003733
Device Name SCS CLOSED SCREW
Applicant
Ortho Tec, LLC
546 Hillgreen Dr.
Beverly Hills,  CA  90212 -4110
Applicant Contact PATRICK BERTRANOU
Correspondent
Ortho Tec, LLC
546 Hillgreen Dr.
Beverly Hills,  CA  90212 -4110
Correspondent Contact PATRICK BERTRANOU
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received12/04/2000
Decision Date 05/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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