SCARLET AC-T

Intervertebral Fusion Device With Bone Graft, Cervical

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Scarlet Ac-t.

Pre-market Notification Details

Device IDK172065
510k NumberK172065
Device Name:SCARLET AC-T
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates,  CH 1228
ContactFranck Pennesi
CorrespondentFranck Pennesi
SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates,  CH 1228
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-07
Decision Date2017-09-29
Summary:summary

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