ADI TiDAL Osteotomy Wedge

Bone Wedge

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 Tidal Osteotomy Wedge.

Pre-market Notification Details

Device IDK191047
501k NumberK191047
Device Name:ADI TiDAL Osteotomy Wedge
ClassificationBone Wedge
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 CodePLF  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-19
Decision Date2019-11-05

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