Identifiers
- 510(k) Number
- K142150 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 system intended for use in the thoracolumbar spine for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma. It is designed to be used with supplemental spinal fixation systems.
The system is supplied for use in the thoracolumbar spine from T1 to L5 and in the cervical spine at one or two levels, with supplemental fixation systems such as the Aesculap MACS TL or S4 Systems. It has been cleared by the FDA under the 510(k) clearance type, with the reference number K142150.
Frequently asked questions
What is the AIS Modulift VBR System used for?
The AIS Modulift VBR System is used for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma in the thoracolumbar spine.
Can the AIS Modulift VBR System be used in the cervical spine?
Yes, the system can be used in the cervical spine at one or two levels, with supplemental fixation systems such as the Aesculap MACS TL or S4 Systems.
What supplemental spinal fixation systems can be used with the AIS Modulift VBR System?
The system is designed to be used with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems.
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 (K142150) — FDA 510(k) | Innolitics, Modulift® S - SPINEMarketGroup
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142150 | Class II | Active |
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Manufacturer
- Manufacturer
- Aesculap Implant System, Inc.
Sources (1)
- FDA 510(k) K142150 24 fields · synced Sep 28, 2026