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 FDA UDI
Model / Reference: 1236-2-862 FDA UDI
Description: X3 Insert FDA UDI

Identifiers

Catalog Number: 1236-2-862 FDA UDI
Primary DI / UDI-DI: 04546540639042 FDA UDI
510(k) Number: K093644 FDA UDI
FDA Product Code: MEH FDA UDI
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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 56.0 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.

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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

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

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI a9b3e318-08c4-41c0-9c5c-902b0399349d 36 fields · synced Jun 6, 2026