SIRION Lateral Lumbar Interbody Fusion

Intervertebral Fusion Device With Bone Graft, Lumbar

Astura Medical, LLC

The following data is part of a premarket notification filed by Astura Medical, Llc with the FDA for Sirion Lateral Lumbar Interbody Fusion.

Pre-market Notification Details

Device IDK202495
510k NumberK202495
Device Name:SIRION Lateral Lumbar Interbody Fusion
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Astura Medical, LLC 4949 W Royal Ln Irving,  TX  75063
ContactParker Kelch
CorrespondentParker Kelch
Astura Medical, LLC 4949 W Royal Ln Irving,  TX  75063
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-01-06

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