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UTF Hip Stem

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 9106-1005

by United Orthopedic Corporation

Identity

Trade Name
UTF Hip Stem EUDAMED
UTF™ Stem FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
United Hip and Knee Non-sterile Reusable Instruments EUDAMED
Anteversion handle FDA UDI
Model / Reference
9106-1005 EUDAMEDFDA UDI
Description
Anteversion handle FDA UDI

Identifiers

Catalog Number
9106-1005 FDA UDI
Primary DI / UDI-DI
04719872172444 EUDAMEDFDA UDI
Basic UDI-DI
471987216TD-Ir-003F4 EUDAMED
Direct Marketing DI
04719872172444 EUDAMED
FDA Product Code
LXH FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

For medical professionals, the United Hip and Knee Non-sterile Reusable Instruments (UTF Hip Stem) are a critical component in orthopedic surgery. This device is designed to facilitate accurate and efficient implantation of hip and knee replacements, reducing the risk of complications and improving patient outcomes.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Orthopedic Corporation
EUDAMED SRN
TW-MF-000009523
Authorised Representative
mdi Europa GmbH DE-AR-000006218

Sources (2)

  • EUDAMED 00a23bb3-3bea-4c51-85ed-7f9b63ec780c 61 fields · synced Oct 6, 2026
  • FDA UDI d883898e-a955-4b9b-bdfc-f661c19eb2d1 35 fields · synced May 25, 2026