← Back to catalogue

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 surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Washer FDA UDI
Model / Reference
1801-W0000 FDA UDI
Description
Washer FDA UDI

Identifiers

Catalog Number
1801-W0000 FDA UDI
Primary DI / UDI-DI
10888857025196 FDA UDI
FDA Product Code
MNH FDA UDI
OSH FDA UDI
NKB FDA UDI
KWP FDA UDI
MNI FDA UDI
KWQ FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI fdf47211-5210-4b59-a4eb-a5bd57526cd2 35 fields · synced May 31, 2026