GII Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Coligne AG

The following data is part of a premarket notification filed by Coligne Ag with the FDA for Gii Spinal Fixation System.

Pre-market Notification Details

Device IDK210306
510k NumberK210306
Device Name:GII Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Coligne AG Utoquai 43 Zurich,  CH 8008
ContactRobert B Lange
CorrespondentJ.d. Webb
The OrthoMedix Group, Inc. 4313 W. 3800, S. West Haven,  UT  84401
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-03
Decision Date2021-05-19

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