Restor3d TiDAL Lumbar Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Restor3d

The following data is part of a premarket notification filed by Restor3d with the FDA for Restor3d Tidal Lumbar Interbody Fusion Device.

Pre-market Notification Details

Device IDK220523
510k NumberK220523
Device Name:Restor3d TiDAL Lumbar Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Restor3d 404 Hunt St. Suite 500 Durham,  NC  27701
ContactShyam Patel
CorrespondentShyam Patel
Restor3d 404 Hunt St. Suite 500 Durham,  NC  27701
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-23
Decision Date2022-06-17

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