Libertas

FDA UDI

Class II (US FDA UDI)

by Maxx Orthopedics Inc.

Identity

Trade Name: Libertas FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: UHMWPE Standard Cemented Cup Without snap fit Size 42/22 FDA UDI
Model / Reference: MO-CFNG-42/22 FDA UDI
Description: UHMWPE Standard Cemented Cup Without snap fit Size 42/22 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840333906484 FDA UDI
510(k) Number: K180973 FDA UDI
FDA Product Code: LZO FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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

A comprehensive medical device directory listing for the Libertas Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented openfda:map[code=LZO name:Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented medical_specialty_description:Orthopedic]

Similar devices

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
Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II

Cleared under the same submission

K180973 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: Maxx Orthopedics Inc.

Sources (1)

FDA UDI 700af59a-e041-4f82-bedd-7dcf24211e51 35 fields · synced Jul 15, 2026