Fortress Pedicular Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170268 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fortress Pedicular Fixation System is a type of pedicular fixation system, consisting of screws, rods, and connectors, used to build an implant system to fit a patient's anatomical and physiological needs. It is used in posterior, non-cervical procedures. The system includes titanium alloy screws, curved and straight rods of various diameters, and ConneX Connector devices. The system allows surgeons to create a customized implant system.
The Fortress Pedicular Fixation System is supplied in various configurations and materials. It is authorized under FDA 510K clearance. The system is part of a minimally invasive procedure designed to reduce incision length, dissection, and retraction requirements. The device is manufactured by Spineology Inc.
Frequently asked questions
What is the Fortress Pedicular Fixation System used for?
The Fortress Pedicular Fixation System is used in posterior, non-cervical procedures to build a customized implant system to fit a patient's anatomical and physiological needs.
What materials are included in the Fortress Pedicular Fixation System?
The system includes titanium alloy screws, curved and straight rods of various diameters, and ConneX Connector devices.
Is the Fortress Pedicular Fixation System supplied in different configurations?
Yes, the Fortress Pedicular Fixation System is supplied in various configurations and materials to allow surgeons to create a customized implant system.
What is the regulatory status of the Fortress Pedicular Fixation System?
The Fortress Pedicular Fixation System is authorized under FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
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 FortressTM Pedicular Fixation System ThresholdTM Pedicular Fixation ..., Fortress™ Pedicular Fixation - thespinemarketgroup.com, Fortress Pedicular Fixation System (K152148) — 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 | K170268 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K170268 24 fields · synced Sep 24, 2026