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Arthrex®

FDA UDI

Class I (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
End Cap, Screws FDA UDI
Model / Reference
AR-8964-22 FDA UDI
Description
End Cap, Screws FDA UDI

Identifiers

Catalog Number
AR-8964-22 FDA UDI
Primary DI / UDI-DI
10888867241401 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
External orthopaedic fixation system, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Category: External orthopaedic fixation system, single-use

ArthroX [code:48011 code_status:Active] is a cutting-edge external orthopaedic fixation system designed to help the healing of long bones, including fractures of the femur, tibia and humerus, foot and ankle fractures, joint fusions, and limb lengthening. This single-use device features an assembly of components such as fixators, clamps, rods, rings, pins, bolts, and nuts, ensuring precise stabilization and accurate alignment for optimal treatment outcomes.

Similar devices

Also classified as External orthopaedic fixation system, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI 63241853-f40d-4a11-8d5f-063c6f3a715c 35 fields · synced Jul 12, 2026