World Cup Trial Liner - 28B Hooded 20°

FDA UDI

Class II (US FDA UDI)

by Signature Orthopaedics Pty Ltd

Identity

Trade Name: World Cup Trial Liner - 28B Hooded 20° FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Model / Reference: 112-43-1212 FDA UDI

Identifiers

Primary DI / UDI-DI: 09348215065874 FDA UDI
510(k) Number: K201278 FDA UDI
FDA Product Code: MEH FDA UDI
LPH FDA UDI
KWZ FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

World Cup Trial Liner - 28B Hooded 20° by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K201278 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: Signature Orthopaedics Pty Ltd

Sources (1)

FDA UDI 89c5bc22-7d08-4aa2-b0f9-c204dcbb346e 33 fields · synced Jun 1, 2026