Restor3d MTP Implant

Prosthesis, Toe, Hemi-, Phalangeal

Restor3d, Inc.

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

Pre-market Notification Details

Device IDK201393
510k NumberK201393
Device Name:Restor3d MTP Implant
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant Restor3d, Inc. 311 W Corporation St Durham,  NC  27701
ContactNathan Evans
CorrespondentJillian Udell
Restor3d, Inc. 311 W Corporation St Durham,  NC  27701
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-27
Decision Date2022-05-25

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