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Union MAX Cervical Plate System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240515

by Ulrich Medical Usa, Inc.

Identifiers

510(k) Number
K240515 FDA 510(k)
FDA Product Code
KWQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3060 FDA 510(k)
Regulation Number
888.3060 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Union MAX Cervical Plate System is a medical device intended for anterior fixation of the cervical spine from C2 to T1. It is used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease.

This system offers standard and midline options, as well as constrained and semi-constrained configurations. It has received FDA 510k clearance under K240515.

Frequently asked questions

What is the intended use of the uNion MAX Cervical Plate System?

This system is intended for the anterior fixation of the cervical spine, specifically spanning from the C2 to T1 vertebrae. It is designed to provide stabilization of the anterior cervical spine as an adjunct to fusion for patients diagnosed with degenerative disc disease.

What configuration options are available for this cervical plate system?

The uNion MAX Cervical Plate System offers both standard and midline placement options. Additionally, surgeons can choose between constrained and semi-constrained configurations to best suit the specific requirements of the spinal stabilization procedure.

What is the regulatory status of the uNion MAX Cervical Plate System?

The uNion MAX Cervical Plate System has received FDA 510k clearance under K240515. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended use.

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: uNion® - Cervical Plate System, PDF ulrich medical_UNIO BRO 04 2024, uNion® cervical plate system - SPINEMarketGroup, PDF March 18, 2024 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ulrich Medical Usa, Inc.

Sources (1)

  • FDA 510(k) K240515 24 fields · synced Sep 26, 2026