ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS

Orthosis, Spinal Pedicle Fixation

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Spinal System, Domino And Tube Connectors.

Pre-market Notification Details

Device IDK030958
510k NumberK030958
Device Name:ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
ClassificationOrthosis, Spinal Pedicle Fixation
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 CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-27
Decision Date2003-11-20
Summary:summary

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