U2 Total Knee System

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name: U2 Total Knee System FDA UDI
Generic Name: Cruciate-retaining total knee prosthesis FDA UDI
Device Name: Patella, Asymmetric Onset, E-XPE, PF+, Large, 35×39mm Dia. 10mm Thick FDA UDI
Model / Reference: 2403-5640 FDA UDI
Description: Patella, Asymmetric Onset, E-XPE, PF+, Large, 35×39mm Dia. 10mm Thick FDA UDI

Identifiers

Catalog Number: 2403-5640 FDA UDI
Primary DI / UDI-DI: 04719886896435 FDA UDI
FDA Product Code: MBH FDA UDI
JWH FDA UDI
KRO FDA UDI
GMDN Term: Cruciate-retaining total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
888.3560 FDA UDI
888.3510 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: Posterior-stabilized total knee prosthesis Cruciate-retaining total knee prosthesis Rotating hinged total knee prosthesis

U2 Total Knee System by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rotating hinged total knee prosthesis.

TRIATHLON — Howmedica Osteonics Corp. · Class II
LEGION — Smith & Nephew, Inc. · Class II
AS ENDURO — AESCULAP, INC. · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
ATTUNE LPS — DEPUY (IRELAND) · Class II
TRIATHLON — Howmedica Osteonics Corp. · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
LEGION — Smith & Nephew, Inc. · Class II

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: United Orthopedic Corp.

Sources (1)

FDA UDI 021910d2-bedc-4a27-af0f-78dcddfa07d7 35 fields · synced May 30, 2026