OSTAPEK VBR SYSTEM

Spinal Vertebral Body Replacement Device

CO-LIGNE AG

The following data is part of a premarket notification filed by Co-ligne Ag with the FDA for Ostapek Vbr System.

Pre-market Notification Details

Device IDK072326
510k NumberK072326
Device Name:OSTAPEK VBR SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant CO-LIGNE AG 1070 CONRAD AVENUE, SUITE 230 Concord,  CA  94520
ContactDavid Schlerf
CorrespondentDavid Schlerf
CO-LIGNE AG 1070 CONRAD AVENUE, SUITE 230 Concord,  CA  94520
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-20
Decision Date2008-06-24
Summary:summary

NIH GUDID Devices

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