Cortina MAX Lumbar Cage System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192248 FDA 510(k)
- FDA Product Code
- MAX 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 Cortina MAX Lumbar Cage System is an intervertebral body fusion device classified under 21 CFR 888.3080. It is designed to provide spinal stabilization by facilitating fusion between lumbar vertebrae, utilizing a medical-grade PEEK material with integrated titanium markers for enhanced visibility during surgical procedures.
This system is supplied as a sterile, single-use device intended for use in spinal fusion surgeries. It is regulated under FDA 510(k) clearance (K192248) and is manufactured by Neurostructures, Inc. The device is engineered to optimize endplate contact and resist subsidence, ensuring stability and promoting successful fusion outcomes.
Frequently asked questions
What is the Cortina MAX Lumbar Cage System used for?
The Cortina MAX Lumbar Cage System is designed to provide spinal stabilization by facilitating fusion between lumbar vertebrae. It is specifically engineered to optimize endplate contact and reduce the risk of subsidence, promoting successful fusion outcomes in spinal surgeries.
What material is the Cortina MAX Lumbar Cage System made from?
The device is constructed from medical-grade PEEK (polyether ether ketone), a biocompatible material known for its strength and stability in spinal applications. Integrated titanium markers also enhance visibility during surgical procedures.
Is the Cortina MAX Lumbar Cage System sterile and single-use?
Yes, the Cortina MAX Lumbar Cage System is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining consistent performance for each surgical procedure.
What regulatory clearance does the Cortina MAX Lumbar Cage System hold?
The device holds FDA 510(k) clearance under the classification 21 CFR 888.3080, with a clearance number of K192248. It was determined to be substantially equivalent to a predicate device through a special review process by the Orthopedic (OR) Advisory Committee.
How does the design of the Cortina MAX Lumbar Cage System improve fusion outcomes?
The system is engineered to maximize endplate contact, which enhances primary stability and reduces the likelihood of subsidence—a common complication in spinal fusion surgeries. The integrated titanium markers also improve intraoperative visibility, aiding in precise placement.
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: Cortina [MAX] Lumbar Cage System (K180431) — FDA 510(k) | Innolitics, NeuroStructures - NuGen Surgical, Cortina™ Lumbar Cage System (K171914) — FDA 510(k) | Innolitics, K180431 FDA 510 (k) - Cortina [MAX] Lumbar Cage System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192248 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurostructures, Inc
- FDA Applicant
- Neurostructures, Inc.
Sources (1)
- FDA 510(k) K192248 24 fields · synced Oct 1, 2026