X3

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: X3 FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: X3 Insert for ADM/ MDM FDA UDI
Model / Reference: 1236-2-854 FDA UDI
Description: X3 Insert for ADM/ MDM FDA UDI

Identifiers

Catalog Number: 1236-2-854 FDA UDI
Primary DI / UDI-DI: 04546540639004 FDA UDI
510(k) Number: K093644 FDA UDI
FDA Product Code: LZO FDA UDI
MEH 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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 48.0 Millimeter FDA UDI
Lumen/Inner Diameter — 28.0 Millimeter FDA UDI

Category: Non-constrained polyethylene acetabular liner

X3 by Howmedica Osteonics Corp. — 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
PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II

Cleared under the same submission

K093644 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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 8ddb05a7-f7a9-4978-8f83-2172be931ba8 36 fields · synced Jun 8, 2026