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Varilift -c

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120603

by Wenzel Spine

Identifiers

510(k) Number
K120603 FDA 510(k)
FDA Product Code
ODP 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 VariLift-C is a standalone lumbar interbody fusion device designed for spinal stabilization. Classified under the product code ODP, it is intended for use in lumbar interbody fusion procedures, providing structural support to the spine while promoting bone fusion between vertebrae. Its expandable design allows for precise placement and stabilization of the intervertebral space, facilitating proper alignment and healing.

The VariLift-C is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K120603) and falls under the Orthopedic advisory committee classification. The device is manufactured by Wenzel Spine and is intended for use in surgical settings, adhering to standard aseptic techniques. No specific MRI safety information is provided, and sizes or additional handling instructions are not detailed in the available data.

Frequently asked questions

What is the VariLift-C designed for in spinal surgery?

The VariLift-C is a standalone lumbar interbody fusion device intended specifically for lumbar interbody fusion procedures. It provides structural support to the spine while promoting bone fusion between adjacent vertebrae. Its expandable design allows for precise placement and stabilization of the intervertebral space, ensuring proper alignment and facilitating the healing process.

How is the VariLift-C supplied and intended for use?

The VariLift-C is supplied sterile and is designed for single-use only. This ensures optimal safety and sterility in surgical settings, adhering to standard aseptic techniques. It is manufactured by Wenzel Spine and is intended exclusively for use in surgical environments.

Is the VariLift-C reusable or single-use, and why?

The VariLift-C is intended for single-use only. This design choice aligns with best practices for medical devices in spinal surgery to minimize infection risks, maintain sterility, and ensure consistent performance. Reuse could compromise sterility and integrity, which are critical for spinal fusion procedures.

What regulatory clearance does the VariLift-C hold?

The VariLift-C holds FDA 510(k) clearance under the reference number K120603. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for spinal interbody fusion devices under the Orthopedic advisory committee classification.

Are there specific handling or storage instructions for the VariLift-C?

The available data does not provide detailed handling or storage instructions for the VariLift-C. However, as a sterile, single-use device, it should be stored in accordance with standard medical device protocols to preserve sterility until use. Surgical settings should follow aseptic techniques to ensure proper handling and minimize contamination risks.

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: S-LIF for Patients - Wenzel Spine, VariLift®-LX - SPINEMarketGroup, Wenzel Spine

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wenzel Spine

Sources (1)

  • FDA 510(k) K120603 24 fields · synced Oct 1, 2026