Fortress Pedicle Screw System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140010 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 Pedicle Screw System is a spinal fixation device used for surgical stabilization of the spine. It consists of pedicle screws and associated components designed to provide immobilization and stabilization of spinal segments.
The system is supplied as a sterile, single-use device and is intended for implantation during spinal fusion procedures. It is available in various sizes and models, with FDA 510(k) clearance under product code NKB for orthopedic use.
Frequently asked questions
What is the Fortress Pedicle Screw System used for?
The Fortress Pedicle Screw System is a spinal fixation device used for surgical stabilization of the spine. It provides immobilization and stabilization of spinal segments during spinal fusion procedures.
How is the Fortress Pedicle Screw System supplied?
The system is supplied as a sterile, single-use device that is intended for implantation during spinal fusion procedures. It comes in various sizes and models to accommodate different patient needs.
What regulatory clearance does the Fortress Pedicle Screw System have?
The Fortress Pedicle Screw System has FDA 510(k) clearance under product code NKB for orthopedic use. It was determined to be substantially equivalent through a traditional review process.
Can the Fortress Pedicle Screw System be reused?
No, the Fortress Pedicle Screw System is supplied as a sterile, single-use device and should not be reused for patient safety and regulatory compliance reasons.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140010 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K140010 24 fields · synced Sep 23, 2026