restor3d MTP

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: restor3d MTP FDA UDI
Generic Name: Partial metatarsophalangeal joint prosthesis FDA UDI
Device Name: CoCr MTP Implant, Small FDA UDI
Model / Reference: 1103-141220 FDA UDI
Description: CoCr MTP Implant, Small FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097505220 FDA UDI
510(k) Number: K201393 FDA UDI
FDA Product Code: KWD FDA UDI
GMDN Term: Partial metatarsophalangeal joint prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Partial metatarsophalangeal joint prosthesis

restor3d MTP by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partial metatarsophalangeal joint prosthesis.

TOE JOINT TITANIUM NPC LG 23MM — BIOPRO, INC. · Class II
MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
TOE NON POROUS COATED SMALL 17mm — BIOPRO, INC. · Class II
Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
OsteoMed — Osteomed Corp. · U
Arthrex® — Arthrex, Inc. · Class II
MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

Cleared under the same submission

K201393 also covers:

restor3d MTP — Restor3D
restor3d MTP — Restor3D

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Restor3D

Sources (1)

FDA UDI ca1be3be-ba1b-4fd2-9b28-47d1dd0bee1d 34 fields · synced May 30, 2026