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U2™ Knee

FDA UDI

Class I (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name
U2™ Knee FDA UDI
Generic Name
Osteotomy guide, reusable FDA UDI
Device Name
Femoral chamfer resection guide, #5 FDA UDI
Model / Reference
9304-2005-RA FDA UDI
Description
Femoral chamfer resection guide, #5 FDA UDI

Identifiers

Catalog Number
9304-2005-RA FDA UDI
Primary DI / UDI-DI
04719872157601 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Osteotomy guide, 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: Osteotomy guide, reusable

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

Similar devices

Also classified as Osteotomy guide, 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 33a6db16-7888-453c-9399-10d16010a723 36 fields · synced May 30, 2026