ARI™ Anterior Staple System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: ARI™ Anterior Staple System FDA UDI
Generic Name: Orthopaedic bone staple, non-adjustable FDA UDI
Device Name: Single Hole Staple FDA UDI
Model / Reference: 1801-D1515 FDA UDI
Description: Single Hole Staple FDA UDI

Identifiers

Catalog Number: 1801-D1515 FDA UDI
Primary DI / UDI-DI: 10888857025110 FDA UDI
FDA Product Code: OSH FDA UDI
MNH FDA UDI
KWQ FDA UDI
MNI FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term: Orthopaedic bone staple, non-adjustable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3060 FDA UDI
888.3050 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone staple, non-adjustable

ARI™ Anterior Staple System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Speed Arc — Synthes · Class II
JAWS Nitinol Staple System — Paragon 28 · 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: K2m, Inc.

Sources (1)

FDA UDI 1b326a72-0e7a-4bc3-b763-a3bd863fcc79 35 fields · synced May 30, 2026