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Arthrex®

FDA UDI

Class I (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Ligament reconstruction instrument set, reusable FDA UDI
Device Name
ANKLE FUSION PLATING SYSTEM FDA UDI
Model / Reference
AR-8970S FDA UDI
Description
ANKLE FUSION PLATING SYSTEM FDA UDI

Identifiers

Catalog Number
AR-8970S FDA UDI
Primary DI / UDI-DI
00888867133990 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Ligament reconstruction instrument set, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ligament reconstruction instrument set, reusable

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

Similar devices

Also classified as Ligament reconstruction instrument set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI eb706c2b-43b3-4d19-92fc-41318cee403c 35 fields · synced Jun 1, 2026