GII SPINAL FIXATION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

CO-LIGNE AG

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

Pre-market Notification Details

Device IDK051089
510k NumberK051089
Device Name:GII SPINAL FIXATION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant CO-LIGNE AG 200 GREGORY LANE, SUITE C-100 Pleasant Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
CO-LIGNE AG 200 GREGORY LANE, SUITE C-100 Pleasant Hill,  CA  94523 -3389
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-28
Decision Date2005-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640173163695 K051089 000
07640173163619 K051089 000
07640173163626 K051089 000
07640173163633 K051089 000
07640173163640 K051089 000
07640173163657 K051089 000
07640173163664 K051089 000
07640173163671 K051089 000
07640173163688 K051089 000
07640173163602 K051089 000

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