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Vertiflex Spinal Screw System

by Vertiflex (Tm), Incorporated 510(k)

Active United States

510(k) K062670

Overview

The Vertiflex Spinal Screw System is a posterior, noncervical pedicle screw device designed for spinal stabilization. It is classified as a spinal fixation system intended to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion. This system addresses acute and chronic instabilities in the thoracic, lumbar, and sacral spine, including degenerative disc disease.

This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K062670) with a traditional review pathway. It is intended for use in orthopedic surgical settings and is not indicated for MRI environments. The device is distributed in sizes and configurations suitable for the specified spinal regions, with sterility maintained through standard surgical packaging protocols.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062670 Date12 Jan 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Vertiflex (Tm), Incorporated

Questions

  • What is the Vertiflex Spinal Screw System used for?

    The Vertiflex Spinal Screw System is designed for spinal stabilization in skeletally mature patients as an adjunct to fusion. It addresses acute and chronic instabilities in the thoracic, lumbar, and sacral spine, including those caused by degenerative disc disease. The system provides posterior fixation to immobilize and stabilize spinal segments, ensuring proper alignment during the healing process.

  • Is the Vertiflex Spinal Screw System single-use or reusable?

    The Vertiflex Spinal Screw System is supplied as a reusable medical device. This classification allows for multiple uses within a clinical setting, provided proper sterilization and maintenance protocols are followed between procedures. Reusability helps reduce waste and costs while maintaining regulatory compliance.

  • What spinal regions does the Vertiflex Spinal Screw System support?

    The system is specifically designed for use in the thoracic, lumbar, and sacral spine regions. It includes sizes and configurations tailored to these areas, ensuring compatibility with the anatomical and biomechanical requirements of each segment. This targeted design allows for precise stabilization where it is most needed.

  • How is sterility maintained for the Vertiflex Spinal Screw System?

    Sterility is maintained through standard surgical packaging protocols. The device is packaged in a manner that preserves sterility until the time of use, adhering to industry best practices for reusable medical instruments. Proper sterilization procedures must be followed by the facility prior to reuse to ensure patient safety.

  • Can the Vertiflex Spinal Screw System be used in MRI environments?

    No, the Vertiflex Spinal Screw System is not indicated for use in MRI environments. This limitation is due to the potential risks associated with metallic implants in magnetic resonance imaging, which could cause artifacts or pose safety hazards. Clinicians should verify compatibility with imaging modalities before proceeding with any procedure.