Duraloc

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: DURALOC FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: Duraloc MARATHON ACETABULAR LINER Neutral 28mm ID 52mm OD FDA UDI
Model / Reference: 1220-28-052 FDA UDI
Description: Duraloc MARATHON ACETABULAR LINER Neutral 28mm ID 52mm OD FDA UDI

Identifiers

Catalog Number: 122028052 FDA UDI
Primary DI / UDI-DI: 10603295015079 FDA UDI
510(k) Number: K972596 FDA UDI
K994415 FDA UDI
FDA Product Code: LPH FDA UDI
JDI FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3350 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

FDA UDI

Category: Non-constrained polyethylene acetabular liner

Duraloc by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
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
Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II

Cleared under the same submission

K972596 also covers:

K994415 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

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

Manufacturer

Manufacturer: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI 696ec782-3878-43e6-b394-8e67fec88f6c 36 fields · synced Jun 8, 2026