Skip to content

FORZA XP Expandable Spacer System

by Orthofix US LLC

510(k) K213951

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 · Special NumberK213951 Date5 Jan 2022ClearedStatusActive

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  • Withdrawn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
MAX
FDA applicant
Orthofix US, LLC
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 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 XP Expandable Spacer System is a titanium alloy expandable interbody device used for Posterior Lumbar Interbody Fusion (PLIF) and Transforaminal Lumbar Interbody Fusion (TLIF) procedures. After insertion into the disc space, the interbodies can be expanded to fit the patient anatomy.

The system is supplied with instruments and is designed to be used in spinal fusion procedures. It is manufactured by Orthofix US LLC and has received FDA 510(k) clearance with the product code MAX. The device is intended to maintain disc space height and provide structural support during the fusion process.

Other devices from Orthofix US LLC

See all devices from Orthofix US LLC →