CLARIS PLATE SYSTEM

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 Claris Plate System.

Pre-market Notification Details

Device IDK010369
510k NumberK010369
Device Name:CLARIS PLATE SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills,  CA  90212 -4110
ContactPatrick Bertranou
CorrespondentPatrick Bertranou
ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills,  CA  90212 -4110
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-07
Decision Date2001-05-08

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