Restor3d Metallic Interference Screw

Screw, Fixation, Bone

Restor3D

The following data is part of a premarket notification filed by Restor3d with the FDA for Restor3d Metallic Interference Screw.

Pre-market Notification Details

Device IDK193491
510k NumberK193491
Device Name:Restor3d Metallic Interference Screw
ClassificationScrew, Fixation, Bone
Applicant restor3D 311 W Corporation St Durham,  NC  27701
ContactNathan Evans
CorrespondentNathan Evans
restor3D 311 W Corporation St Durham,  NC  27701
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-03-19

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