Hexanium TLIF

Intervertebral Fusion Device With Bone Graft, Lumbar

SpineVision SAS

The following data is part of a premarket notification filed by Spinevision Sas with the FDA for Hexanium Tlif.

Pre-market Notification Details

Device IDK210359
510k NumberK210359
Device Name:Hexanium TLIF
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SpineVision SAS 10 Rue De La Renaissance Batiment E,  FR 92160
ContactArnaud Brisard
CorrespondentSevrina Ciucci
Lince Consulting LLC 111 Deerwood Road, Suite 200 San Ramon,  CA  94583
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03663136001715 K210359 000
03663136001609 K210359 000
03663136001593 K210359 000
03663136001586 K210359 000
03663136001579 K210359 000
03663136001562 K210359 000
03663136001555 K210359 000
03663136001548 K210359 000
03663136001531 K210359 000
03663136001616 K210359 000
03663136001623 K210359 000
03663136001708 K210359 000
03663136001692 K210359 000
03663136001685 K210359 000
03663136001678 K210359 000
03663136001661 K210359 000
03663136001654 K210359 000
03663136001647 K210359 000
03663136001630 K210359 000
03663136001524 K210359 000

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