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Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Orthopaedic fixation suture button FDA UDI
Device Name
AC TIGHTROPE, TWIN TAIL FDA UDI
Model / Reference
AR-2264 FDA UDI
Description
AC TIGHTROPE, TWIN TAIL FDA UDI

Identifiers

Catalog Number
AR-2264 FDA UDI
Primary DI / UDI-DI
00888867026513 FDA UDI
FDA Product Code
HTN FDA UDI
KGS FDA UDI
GMDN Term
Orthopaedic fixation suture button FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
878.4930 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic fixation suture button

A small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures. This AC TIGHTROPE, TWIN TAIL is typically used for internal fixation of fractures with or without additional fixation devices.

Similar devices

Also classified as Orthopaedic fixation suture button.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI 3fe09007-29f7-4c8c-b6ca-589807292483 35 fields · synced Jul 19, 2026