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FORZA Ti Spacer System

by Orthofix, Inc.

510(k) K203576

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK203576 Date3 Mar 2021ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0895-2026 FDA Class III initiated 3 Nov 2025

    Labeling contains claims that are not consistently present.

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
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 FORZA Ti Spacer System is an orthopedic device intended for intervertebral body fusion to aid in the surgical correction of the spine. It is implanted using a posterior approach and is designed to be used as a standalone device.

The FORZA Ti Spacer System implants are provided sterile. The FORZA Spacer System instruments are supplied non-sterile and must be sterilized prior to use. The device is regulated under FDA 510(k) authorization.

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

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 FORZA Ti Spacer System used for?

    The FORZA Ti Spacer System is an orthopedic device intended for intervertebral body fusion to aid in the surgical correction of the spine.

  • How is the FORZA Ti Spacer System supplied?

    The FORZA Ti Spacer System implants are provided sterile. The FORZA Spacer System instruments are supplied non-sterile and must be sterilized prior to use.

  • What is the regulatory status of the FORZA Ti Spacer System?

    The FORZA Ti Spacer System is regulated under FDA 510(k) authorization.