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AIS Modulift VBR System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133802

by Aesculap Implant System, Inc.

Identifiers

510(k) Number
K133802 FDA 510(k)
FDA Product Code
MQP 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 AIS Modulift VBR System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma, including fracture. It is designed to be used with supplemental spinal fixation systems that have been cleared by the FDA, such as the Aesculap MACS TL or S4 Systems.

The device is supplied as part of a spinal implant system and is indicated for use in surgical procedures involving vertebral body replacement. It has received FDA 510(k) clearance (K133802) and is manufactured by Aesculap Implant System, Inc. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorisations is provided in the data.

Frequently asked questions

What is the AIS Modulift VBR System used for?

The AIS Modulift VBR System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma, including fracture. It is designed to be used with supplemental spinal fixation systems cleared by the FDA, such as the Aesculap MACS TL or S4 Systems.

What regulatory pathway was used for the AIS Modulift VBR System?

The AIS Modulift VBR System received FDA 510(k) clearance under K133802, with a decision date of April 17, 2014, and was found substantially equivalent to a predicate device. The clearance type was traditional, and the product code is MQP.

Who manufactures the AIS Modulift VBR System and where is it located?

The AIS Modulift VBR System is manufactured by Aesculap Implant System, Inc., located at 3773 Corporate Pwky., Center Valley, PA 18034, United States. The applicant and manufacturer are the same entity.

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: PDF Aesculap Modulift Vertebral Body Replacement (Vbr) System (1), AIS MODULIFT VBR SYSTEM (K133802) — FDA 510 (k) | Innolitics, K133802 FDA 510 (k) - AIS MODULIFT VBR SYSTEM

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aesculap Implant System, Inc.

Sources (1)

  • FDA 510(k) K133802 24 fields · synced Sep 26, 2026