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restor3d Total Talus Replacement

FDA UDI

Class Unclassified (US FDA UDI)

by Restor3D

Identity

Trade Name
restor3d Total Talus Replacement FDA UDI
Generic Name
Custom-made hand/foot bone prosthesis FDA UDI
Device Name
Impactor, Flat FDA UDI
Model / Reference
6102-600 FDA UDI
Description
Impactor, Flat FDA UDI

Identifiers

Primary DI / UDI-DI
00840097509891 FDA UDI
PMA Number
H230003 FDA UDI
FDA Product Code
QNN FDA UDI
QYQ FDA UDI
GMDN Term
Custom-made hand/foot bone prosthesis FDA UDI

Classification

Device Class
Unclassified FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement by Restor3D — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made hand/foot bone prosthesis.

Cleared under the same submission

H230003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Restor3D

Sources (1)

  • FDA UDI 824dd059-c91f-41e1-bfc3-1531e10af05b 34 fields · synced May 30, 2026