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U2™ Knee

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name
U2™ Knee FDA UDI
Generic Name
Knee tibia prosthesis trial, reusable FDA UDI
Device Name
Tibial insert trial, CR, plained, #1, 9mm FDA UDI
Model / Reference
2303-2211 FDA UDI
Description
Tibial insert trial, CR, plained, #1, 9mm FDA UDI

Identifiers

Catalog Number
2303-2211 FDA UDI
Primary DI / UDI-DI
04719872168959 FDA UDI
510(k) Number
K120507 FDA UDI
K131116 FDA UDI
K131864 FDA UDI
K132752 FDA UDI
K140073 FDA UDI
K140075 FDA UDI
K150829 FDA UDI
K150832 FDA UDI
K152430 FDA UDI
K161360 FDA UDI
K161705 FDA UDI
FDA Product Code
JWH FDA UDI
MBH FDA UDI
OIY FDA UDI
GMDN Term
Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Knee tibia prosthesis trial, reusable

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

Similar devices

Also classified as Knee tibia prosthesis trial, reusable.

Cleared under the same submission

K120507 also covers:

K131116 also covers:

K131864 also covers:

K132752 also covers:

K140073 also covers:

K140075 also covers:

K150829 also covers:

K150832 also covers:

K152430 also covers:

K161360 also covers:

K161705 also covers:

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 44f2ff84-4e98-40d9-9917-ca86abc157c4 37 fields · synced Jun 8, 2026