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Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation Sys…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142752

by Zimmer Spine, Inc.

Identifiers

510(k) Number
K142752 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This system comprises posterior spinal fixation devices designed for internal fixation of the cervical and upper thoracic spine (C1–T3). It includes polyaxial screws, rods, connectors, and plating systems to stabilize the spine during surgical procedures, such as fusion or trauma stabilization. The components are engineered to provide adjustable fixation angles and secure attachment to vertebrae, facilitating proper alignment and load distribution. The device types include pedicle screws, cervical plating, and modular connectors for versatile application in spinal reconstruction or deformity correction.

The system is supplied sterile and intended for single-use in surgical settings. Components are MRI Conditional as specified in updated instructions for use (IFU), allowing safe imaging under defined conditions. Sizes and configurations vary by subsystem (e.g., pedicle screws, rods) to accommodate different anatomical requirements. Regulatory clearance under FDA 510(k) K142752 confirms compliance with orthopedic device standards, with the submission filed under product code NKB. Storage and handling follow sterile medical device protocols to maintain integrity prior to use.

Frequently asked questions

What is the Nex-Link OCT Cervical Plating System used for?

The Nex-Link OCT Cervical Plating System is designed for internal fixation of the cervical and upper thoracic spine (C1–T3). It is primarily used during surgical procedures such as spinal fusion or trauma stabilization to provide secure attachment to vertebrae, ensuring proper alignment and load distribution. The modular components allow for versatile application in spinal reconstruction or deformity correction.

Is the Nex-Link OCT Cervical Plating System supplied sterile and for single-use?

Yes, the system is supplied sterile and intended for single-use in surgical settings. This ensures patient safety and reduces the risk of infection or contamination, adhering to standard sterile medical device protocols.

Can this system be used with MRI imaging?

Yes, the components of the Nex-Link OCT Cervical Plating System are MRI Conditional, as specified in the updated instructions for use (IFU). This means they can be safely imaged under defined conditions, allowing for post-operative monitoring without interference.

What sizes and configurations are available for the Nex-Link OCT Cervical Plating System?

The system offers varied sizes and configurations tailored to different anatomical requirements. This includes polyaxial screws, rods, connectors, and plating systems designed to accommodate specific spinal needs, ensuring flexibility for surgical applications in cervical and upper thoracic fixation.

How should the Nex-Link OCT Cervical Plating System be stored and handled?

The system must be stored and handled according to sterile medical device protocols to maintain its integrity before use. Proper storage ensures the device remains uncontaminated and ready for surgical procedures, adhering to manufacturer guidelines for optimal performance.

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: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal ..., Minit Posterior Cervical-thoracic Fixation System, Nex-link Spinal ..., PDF Zimmer Spine, Incorporated - Food and Drug Administration, Nex-Link® Spinal Fixation System - SPINEMarketGroup

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zimmer Spine, Inc.

Sources (1)

  • FDA 510(k) K142752 24 fields · synced Oct 5, 2026