← Back to catalogue

U2™ Knee

FDA UDI

Class I (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name
U2™ Knee FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Femoral driver FDA UDI
Model / Reference
9303-5110 FDA UDI
Description
Femoral driver FDA UDI

Identifiers

Catalog Number
9303-5110 FDA UDI
Primary DI / UDI-DI
04719872175032 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™ Knee 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (1)

  • FDA UDI 6fb3e984-7dac-4f1b-89bc-4dcc813dbee0 35 fields · synced May 31, 2026