KHEIRON® Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

S.M.A.I.O.

The following data is part of a premarket notification filed by S.m.a.i.o. with the FDA for Kheiron® Spinal Fixation System.

Pre-market Notification Details

Device IDK211981
510k NumberK211981
Device Name:KHEIRON® Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant S.M.A.I.O. 2, Place Berthe Morisot Parc Technologique Saint-Priest,  FR 69800
ContactJean-Charles Roussouly
CorrespondentJ.D. Webb
The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven,  UT  84401
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-25
Decision Date2022-06-09

Trademark Results [KHEIRON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KHEIRON
KHEIRON
79165301 4872495 Live/Registered
S.M.A.I.O
2015-03-12

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