Logical 20° Hooded Liner

FDA UDI

Class II (US FDA UDI)

by Signature Orthopaedics Pty Ltd

Identity

Trade Name: Logical 20° Hooded Liner FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Model / Reference: 111-12-9850 FDA UDI

Identifiers

Primary DI / UDI-DI: 09348215024765 FDA UDI
510(k) Number: K153131 FDA UDI
FDA Product Code: MEH FDA UDI
LPH FDA UDI
KWZ 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
888.3310 FDA UDI
Commercial Distribution: Not 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

Logical 20° Hooded Liner by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Signature Orthopaedics Pty Ltd

Sources (1)

FDA UDI f5def3f7-748f-452b-a777-6962e8c2dcb6 34 fields · synced Jun 6, 2026

Logical 20° Hooded Liner

Identity

Identifiers

Classification

Clinical & Handling

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)