Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Bioabsorbable orthopaedic bone screw FDA UDI
Device Name: BIO-COMP-TENOD SCRW W/DISP DRV 6.25x15MM FDA UDI
Model / Reference: AR-1562CDS FDA UDI
Description: BIO-COMP-TENOD SCRW W/DISP DRV 6.25x15MM FDA UDI

Identifiers

Catalog Number: AR-1562CDS FDA UDI
Primary DI / UDI-DI: 00888867233980 FDA UDI
FDA Product Code: HWC FDA UDI
MAI FDA UDI
MBI FDA UDI
GMDN Term: Bioabsorbable orthopaedic bone screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
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 Safe FDA UDI

Category: Bioabsorbable orthopaedic bone screw

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

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Also classified as Bioabsorbable orthopaedic bone screw.

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2.0 mm Inion CPS® — Inion , Ltd. · Class II
MILAGRO — Medos International Sàrl · Class II
REUNITE SCREW SYSTEM — Biomet Orthopedics, 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 3ac5753a-dd7b-4eb2-9409-78928515bca8 35 fields · synced Jun 6, 2026