ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01

Appliance, Fixation, Spinal Interlaminal

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 Clip System, Lateral Intermediate Connector, Model Al01.

Pre-market Notification Details

Device IDK031471
510k NumberK031471
Device Name:ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
ClassificationAppliance, Fixation, Spinal Interlaminal
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 CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-09
Decision Date2003-10-10
Summary:summary

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