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FORTEZZA Spinal Stabilization System

by Osso Surgical

510(k) K162576

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162576 Date10 Nov 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FORTEZZA Spinal Stabilization System is a posterior spinal fixation device designed for skeletal mature patients. It is classified as an orthopedic implant intended to provide stabilization as an adjunct to spinal fusion procedures. The system is engineered to address degenerative disc disease and spondylolisthesis in non-cervical regions of the spine. Its design supports structural integrity during the healing process, ensuring proper alignment and stabilization of the spine.

The device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K162576) as a Class II orthopedic product, approved through the Traditional 510(k) pathway. The FORTEZZA System is MRI-safe as per its specifications and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality. It is intended for use in surgical settings by qualified healthcare professionals.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FORTEZZA Spinal Stabilization System used for?

    The FORTEZZA Spinal Stabilization System is designed as an adjunct to spinal fusion procedures for skeletal mature patients with degenerative disc disease or spondylolisthesis in non-cervical spine regions. It provides structural support during the healing process to maintain proper spinal alignment and stability.

  • Is the FORTEZZA System intended for single-use or reuse?

    The FORTEZZA System is explicitly intended for single-use only. This ensures sterility and safety for each surgical procedure, as it is supplied sterile and not engineered for reprocessing.

  • How should the FORTEZZA System be stored to maintain its integrity?

    The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions are critical to ensure the system remains effective for its intended surgical use.

  • Is the FORTEZZA System MRI-safe?

    Yes, the FORTEZZA System is designed to be MRI-safe as per its specifications. This allows for post-operative MRI imaging without interference, provided the system is used as intended.

  • What regulatory pathway was used for FDA clearance of the FORTEZZA System?

    The FORTEZZA Spinal Stabilization System received FDA clearance through the Traditional 510(k) pathway, classified as a Class II orthopedic device. The clearance number is K162576, and it was determined to be substantially equivalent to a predicate device.