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Silicone Toe System

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Silicone Toe System FDA UDI
Generic Name
Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
Device Name
LMP IMPLANT SIZE 20 FDA UDI
Model / Reference
LMP-20T FDA UDI
Description
LMP IMPLANT SIZE 20 FDA UDI

Identifiers

Catalog Number
LMP-20T FDA UDI
Primary DI / UDI-DI
00885556834534 FDA UDI
510(k) Number
K023531 FDA UDI
FDA Product Code
KWH FDA UDI
GMDN Term
Total metatarsophalangeal joint prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3720 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

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

Category: Total metatarsophalangeal joint prosthesis, one-piece

Silicone Toe System by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total metatarsophalangeal joint prosthesis, one-piece.

Cleared under the same submission

K023531 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI c250a942-1327-4f4c-971f-37048de133fc 36 fields · synced Jun 8, 2026