Neo ADVISE Software
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Comerge AG
Identifiers
- 510(k) Number
- K230195 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Neo ADVISE Software is a medical device classified as an intraoperative imaging system (Product Code: OLO) designed to assist in spinal surgery. It calculates the relative positions and distances between implanted Neo Pedicle Screw System screws by analyzing visual data from screw guides, estimating rod length, and visualizing rod positioning for surgical planning.
The software is supplied as a digital tool for use with compatible imaging platforms, such as iPad-based augmented reality systems. It is intended for single-use in sterile surgical environments and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of March 8, 2024. Compliance with MDR (Medical Device Regulation) is also noted, ensuring adherence to European regulatory standards.
Frequently asked questions
What specific surgical planning tasks does the Neo ADVISE software assist with during spinal procedures?
The Neo ADVISE software helps surgeons by calculating the relative positions and distances between Neo Pedicle Screw System screws using visual data from screw guides. It also estimates rod length and provides visualizations for rod positioning, which aids in precise intraoperative planning and alignment during spinal surgery.
How is the Neo ADVISE software supplied, and what kind of devices is it designed to work with?
The Neo ADVISE software is supplied as a digital tool and is intended for use with compatible imaging platforms, specifically iPad-based augmented reality systems. It is not a standalone hardware device but rather a software solution integrated into these platforms for surgical assistance.
Is the Neo ADVISE software intended for reuse in multiple surgeries, or is it designed for single-use?
The Neo ADVISE software is explicitly designed for single-use in sterile surgical environments. This ensures hygiene and safety standards are maintained during each procedure, as it is not meant to be reused across multiple surgeries.
What regulatory pathways has the Neo ADVISE software followed, and what does this mean for its use?
The Neo ADVISE software has received FDA 510(k) clearance under the Traditional pathway, with a decision date of March 8, 2024, and also complies with the Medical Device Regulation (MDR) for European markets. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets EU regulatory standards for safety and 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: Comerge - Case study: Neo Medical, Neo ADVISE software by Comerge AG | FDA 510 (k) Summary, Comerge - Case study: Neo Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230195 | Class II | Active |
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Manufacturer
- Manufacturer
- Comerge AG
Sources (2)
- FDA 510(k) K230195 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026