Ceramax

FDA UDI

Class III (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: CERAMAX FDA UDI
Generic Name: Ceramic acetabular liner FDA UDI
Device Name: CERAMAX Ceramic Insert NEUTRAL 60mm OD 28mm ID FDA UDI
Model / Reference: 1218-89-660 FDA UDI
Description: CERAMAX Ceramic Insert NEUTRAL 60mm OD 28mm ID FDA UDI

Identifiers

Catalog Number: 121889660 FDA UDI
Primary DI / UDI-DI: 10603295012719 FDA UDI
FDA Product Code: MRA FDA UDI
GMDN Term: Ceramic acetabular liner FDA UDI

Classification

Device Class: Class III 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: Ceramic acetabular liner

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

Similar devices

Also classified as Ceramic acetabular liner.

BIOLOX delta — Smith & Nephew, Inc. · Class III
Lineage — MicroPort Orthopedics Inc. · Class III
R3 — Smith & Nephew, Inc. · Class III
R3 ACETABULAR — Smith & Nephew, Inc. · Class III
R3 ACETABULAR — Smith & Nephew, Inc. · Class III
R3 ACETABULAR — Smith & Nephew, Inc. · Class III
BIRMINGHAM HIP — Smith & Nephew, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class III

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

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

Manufacturer

Manufacturer: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI 8d1d3a83-d03d-4fcb-81a8-7291d38d7252 35 fields · synced Jun 8, 2026