ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ

Orthosis, Spondylolisthesis Spinal 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 Clip System, Types Bd And Bj.

Pre-market Notification Details

Device IDK023994
510k NumberK023994
Device Name:ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
ClassificationOrthosis, Spondylolisthesis Spinal 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 CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-03
Decision Date2003-02-05
Summary:summary

NIH GUDID Devices

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