Restor3d Utility Wedge

Bone Wedge

Restor3d, Inc.

The following data is part of a premarket notification filed by Restor3d, Inc. with the FDA for Restor3d Utility Wedge.

Pre-market Notification Details

Device IDK201314
510k NumberK201314
Device Name:Restor3d Utility Wedge
ClassificationBone Wedge
Applicant restor3d, Inc. 311 W Corporation St Durham,  NC  27701
ContactMichaela Pigue
CorrespondentMichaela Pigue
restor3d, Inc. 311 W Corporation St Durham,  NC  27701
Product CodePLF  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-18
Decision Date2021-06-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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