Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: LOW PROFILE SCREW, TI, 4.5 X 30MM FDA UDI
Model / Reference: AR-8545-30 FDA UDI
Description: LOW PROFILE SCREW, TI, 4.5 X 30MM FDA UDI

Identifiers

Catalog Number: AR-8545-30 FDA UDI
Primary DI / UDI-DI: 00888867124523 FDA UDI
FDA Product Code: HRS FDA UDI
HTN FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Arthrex's low-profile screw, Ti, 4.5 x 30mm, is a small, threaded implantable rod designed for internal orthopaedic fixation in various limb bones, providing direct interfragmentary stabilization of fractured bones. This device is intended for non-intramedullary fixation/arthrodesis and has a drive at its proximal end for easy screw insertion with a standard screwdriver.

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II
ARIX System Bone Screw — Jeil Medical Corporation · Class II
Creed Ortholucent Implants — Glw, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arthrex, Inc.

Sources (1)

FDA UDI 17639c48-a1d2-4acc-bacf-d3a2930b7f68 35 fields · synced Jul 18, 2026