FDA.report

510(k) K201393

Device
Restor3d MTP Implant
Applicant
Restor3d, Inc.
510(k) number
K201393
Product code
KWD  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-25
Date received
2020-05-27
Regulation
888.3730
Classification name
Prosthesis, Toe, Hemi-, Phalangeal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nathan Evans
Address
311 W. Corporation St. Durham NC US 27701 27701

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00840097505244restor3d MTPRestor3d2023-04-03
00840097505237restor3d MTPRestor3d2023-04-03
00840097505220restor3d MTPRestor3d2023-04-03

Legacy Summary

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FDA Review

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