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: LO-PRO SCRW,PT THD,TI,4.5MMX 65MM, STRL FDA UDI
Model / Reference: AR-9045-65PTS FDA UDI
Description: LO-PRO SCRW,PT THD,TI,4.5MMX 65MM, STRL FDA UDI

Identifiers

Catalog Number: AR-9045-65PTS FDA UDI
Primary DI / UDI-DI: 00888867242944 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 e53297d2-fb21-410c-b1bf-d05c50081b11 35 fields · synced May 30, 2026