S-Rom Marathon

FDA UDI

Class III (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: S-ROM MARATHON FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: S-ROM MARATHON ACETABULAR LINER 32mm +3 10 DEGREES L SERIES FDA UDI
Model / Reference: 1220-72-332 FDA UDI
Description: S-ROM MARATHON ACETABULAR LINER 32mm +3 10 DEGREES L SERIES FDA UDI

Identifiers

Catalog Number: 122072332 FDA UDI
Primary DI / UDI-DI: 10603295015918 FDA UDI
510(k) Number: K924492 FDA UDI
FDA Product Code: KWA FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 888.3330 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

S-Rom Marathon by Depuy Orthopaedics, Inc. — Class III — 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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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

K924492 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 III	Pending data

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Manufacturer

Manufacturer: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI 5b914662-ed1d-4642-857f-e41aa9e8ce3b 36 fields · synced Jun 8, 2026