ORIA CERVICAL PLATES

Appliance, Fixation, Spinal Intervertebral Body

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Cervical Plates.

Pre-market Notification Details

Device IDK023377
510k NumberK023377
Device Name:ORIA CERVICAL PLATES
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills,  CA  90212
ContactPatrick Bertranou
CorrespondentPatrick Bertranou
ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills,  CA  90212
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-08
Decision Date2003-03-04

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