TruMatch Personalised Solutions Shoulder System

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name: TruMatch Personalised Solutions Shoulder System FDA UDI
Generic Name: Custom-made organ/bone anatomy model FDA UDI
Device Name: TRUMATCH SHOULDER PSI STEPTECH SCAPULA MODEL FDA UDI
Model / Reference: 225502002 FDA UDI
Description: TRUMATCH SHOULDER PSI STEPTECH SCAPULA MODEL FDA UDI

Identifiers

Catalog Number: 225502002 FDA UDI
Primary DI / UDI-DI: 05420060363054 FDA UDI
510(k) Number: K172054 FDA UDI
FDA Product Code: KWS FDA UDI
GMDN Term: Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made organ/bone anatomy model

TruMatch Personalised Solutions Shoulder System by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K172054 also covers:

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: Materialise NV

Sources (1)

FDA UDI 43e71bca-9bf3-466a-9f35-9d070031bfdb 35 fields · synced May 31, 2026