ADI Cervical Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Cervical

Additive Device, Inc. (ADI) D/b/a Restor3d

The following data is part of a premarket notification filed by Additive Device, Inc. (adi) D/b/a Restor3d with the FDA for Adi Cervical Interbody Fusion Device.

Pre-market Notification Details

Device IDK191812
510k NumberK191812
Device Name:ADI Cervical Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Additive Device, Inc. (ADI) D/b/a Restor3d 311 W Corporation St Durham,  NC  27701
ContactNathan Evans
CorrespondentNathan Evans
Additive Device, Inc. (ADI) D/b/a Restor3d 311 W Corporation St Durham,  NC  27701
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-05
Decision Date2019-10-24
Summary:summary

NIH GUDID Devices

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