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A-Link Z

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201671

by Acuity Surgical Devices, Llc

Identifiers

510(k) Number
K201671 FDA 510(k)
FDA Product Code
OVD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The A-Link Z is an anterolateral cage designed for intervertebral body fusion of the spine in skeletally mature patients. It features four anchor points for the insertion of titanium alloy fixed angle screws to promote long-term stability.

This stand-alone device is implanted through a single incision and is intended for use with allogenic or autograft bone graft. It is supplied as a single-use system, with the 10-277097 model available in a 27mm x 9mm x 7° size. The device has received FDA 510k clearance.

Frequently asked questions

What is the intended use of the A-Link Z?

The A-Link Z is an anterolateral cage designed to facilitate intervertebral body fusion of the spine in patients who are skeletally mature. It is a stand-alone system that requires the use of allogenic or autograft bone graft to support the fusion process.

How is the A-Link Z system supplied and used?

This device is supplied as a single-use system, meaning it is intended for one-time application only and must not be reused. It is implanted through a single incision and utilizes four anchor points for the insertion of titanium alloy fixed angle screws to ensure long-term stability.

What are the dimensions of the available A-Link Z model?

The A-Link Z is currently available in model 10-277097, which features dimensions of 27mm x 9mm x 7°.

What is the regulatory status of this device?

The A-Link Z has received FDA 510k clearance under K-number K201671, having been determined to be substantially equivalent to existing devices.

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: ACUITY SURGICAL DEVICES, LLC 10-277097 A Link Z - RevMed, A-Link Z - thespinemarketgroup.com, PDF Acuity Surgical Devices, LLC ℅ Lucie Dalet

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acuity Surgical Devices, Llc

Sources (1)

  • FDA 510(k) K201671 24 fields · synced Sep 27, 2026