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U2 Total Knee System

FDA UDI

Class I (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name
U2 Total Knee System FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Patellar capture, onset, NON-CEM, M, Ø32mm FDA UDI
Model / Reference
9404-5230 FDA UDI
Description
Patellar capture, onset, NON-CEM, M, Ø32mm FDA UDI

Identifiers

Catalog Number
9404-5230 FDA UDI
Primary DI / UDI-DI
04719886904116 FDA UDI
FDA Product Code
HWR FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

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

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (1)

  • FDA UDI 0eae639a-00aa-49c6-a318-44e982e36958 35 fields · synced Jun 8, 2026