Firefly Cervical Navigation Guide
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220132 FDA 510(k)
- FDA Product Code
- QSD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3075 FDA 510(k)
- Regulation Number
- 888.3075 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Firefly Cervical Navigation Guide is a patient-specific, 3D-printed posterior cervical screw placement guide. It is designed to assist physicians in the planning and placement of pedicle screws during spinal fusion procedures.
This device is manufactured using Multi Jet Fusion technology and is provided as a custom solution for individual cases. It has received FDA 510(k) clearance under K220132 and is classified as a class 2 medical device under regulation number 888.3075.
Frequently asked questions
What is the primary purpose of the FIREFLY Cervical Navigation Guide?
This device is a patient-specific, 3D-printed guide intended to assist physicians with the planning and placement of pedicle screws during spinal fusion procedures.
How is the FIREFLY Cervical Navigation Guide manufactured?
The guide is produced using Multi Jet Fusion technology. Because it is a custom solution, each unit is specifically manufactured for an individual patient case.
What is the regulatory status of this device?
The FIREFLY Cervical Navigation Guide has received FDA 510(k) clearance under K220132. It is classified as a class 2 medical device under regulation number 888.3075.
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: FIREFLY® - Mighty Oak Medical, Mighty Oak Medical, K220132 FDA 510 (k) - FIREFLY Cervical Navigation Guide, FIREFLY® Cervical Navigation Guide (K220132) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220132 | Class II | Active |
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Manufacturer
- Manufacturer
- Mighty Oak Medical, Inc.
Sources (1)
- FDA 510(k) K220132 24 fields · synced Oct 6, 2026