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Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221333

by Acumed, LLC

Identifiers

510(k) Number
K221333 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Acumed Acutrak and Acutrak 2 systems are metallic bone fixation fasteners used for fracture fixation, fusions, and osteotomies. These devices provide mechanical stability to bone fragments during healing and are implanted by orthopedic surgeons in sterile operating rooms.

The Acumed Acutrak System- MR Conditional and Acumed Acturak 2 System- MR Conditional are supplied as sterile devices intended for single use. They are MRI conditional, meaning they can be safely used in an MRI environment under specific conditions. The systems are available in various sizes and must be stored in a controlled environment to maintain sterility.

Frequently asked questions

What is the intended use of the Acumed Acutrak and Acutrak 2 systems?

These systems are metallic bone fixation fasteners used for fracture fixation, fusions, and osteotomies. They provide mechanical stability to bone fragments during the healing process and are implanted by orthopedic surgeons.

Are these devices intended for single use?

Yes, the Acumed Acutrak System- MR Conditional and Acumed Acturak 2 System- MR Conditional are supplied as sterile devices intended for single use.

Can these devices be used in an MRI environment?

Yes, these systems are MRI conditional, meaning they can be safely used in an MRI environment under specific conditions.

How should these devices be stored?

The systems are available in various sizes and must be stored in a controlled environment to maintain their sterility.

What is the regulatory status of these devices?

These devices have received FDA 510(k) clearance, which is a traditional clearance type indicating they are substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ..., Acutrak 2 Headless Compression Screw System | Acumed, Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acumed, LLC

Sources (1)

  • FDA 510(k) K221333 24 fields · synced Sep 19, 2026