Logical 10d Face Changing Liner Vit-E

FDA UDI

Class II (US FDA UDI)

by Signature Orthopaedics Pty Ltd

Identity

Trade Name: Logical 10d Face Changing Liner Vit-E FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Model / Reference: 111-12-9305E FDA UDI

Identifiers

Primary DI / UDI-DI: 09348215133658 FDA UDI
510(k) Number: K241690 FDA UDI
FDA Product Code: MEH FDA UDI
LPH FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

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

Category: Non-constrained polyethylene acetabular liner

Logical 10d Face Changing Liner Vit-E by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Non-constrained polyethylene acetabular liner.

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PRIME — MicroPort Orthopedics Inc. · Class II
G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II

Cleared under the same submission

K241690 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 496b1704-dce9-48c3-b7d2-673ee1863e25 33 fields · synced May 30, 2026