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Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
Straight Attachment Arm FDA UDI
Model / Reference
AR-8964-27 FDA UDI
Description
Straight Attachment Arm FDA UDI

Identifiers

Catalog Number
AR-8964-27 FDA UDI
Primary DI / UDI-DI
00888867329126 FDA UDI
510(k) Number
K122208 FDA UDI
FDA Product Code
NDK FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: General external orthopaedic fixation system implantation kit, reusable

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

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, reusable.

Cleared under the same submission

K122208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI e12bf235-07f3-4201-9e7c-cae9246a8e32 36 fields · synced Jun 8, 2026