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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 intervertebral body
510(k) Number K023377
Device Name ORIA CERVICAL PLATES
Applicant
ORTHOTEC, L.L.C.
9595 WILSHIRE BLVD. SUITE 502
BEVERLY HILLS,  CA  90212
Applicant Contact PATRICK BERTRANOU
Correspondent
ORTHOTEC, L.L.C.
9595 WILSHIRE BLVD. SUITE 502
BEVERLY HILLS,  CA  90212
Correspondent Contact PATRICK BERTRANOU
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/08/2002
Decision Date 03/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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