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DualX

by Innovasive, Inc.

510(k) K181397

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 NumberK181397 Date27 Sep 2018ClearedStatusActive

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  • Withdrawn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
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 DualX Interbody Device is a titanium spinal implant classified as an interbody fusion device, designed for lumbar spine procedures. It features a dual-expanding mechanism to facilitate bone fusion by maintaining proper spacing between vertebrae. This device is intended for use in anterior lumbar interbody fusion (ALIF) or posterior lumbar interbody fusion (PLIF) surgeries, providing structural support and promoting bony integration.

The device is supplied sterile and intended for single-use. It is manufactured from titanium and is regulated under FDA 510(k) clearance (K181397) as substantially equivalent to a predicate device. Storage and handling must comply with sterile medical device protocols, and its use is restricted to qualified surgical settings. No MRI safety information is specified, and sizes or additional technical specifications are not provided in the available data.

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 DualX Interbody Device used for?

    The DualX Interbody Device is designed specifically for anterior lumbar interbody fusion (ALIF) or posterior lumbar interbody fusion (PLIF) surgeries. It provides structural support to the lumbar spine by maintaining proper spacing between vertebrae, facilitating bone fusion and promoting bony integration. This helps stabilize the spine and restore function in patients with degenerative disc disease or other spinal pathologies.

  • Is the DualX device sterile and single-use?

    Yes, the DualX Interbody Device is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for optimal performance during surgery. Sterile medical devices must be handled with care to preserve sterility until use.

  • What material is the DualX device made from?

    The DualX Interbody Device is manufactured from titanium, a biocompatible material known for its strength, durability, and resistance to corrosion. Titanium is commonly used in spinal implants due to its ability to integrate well with bone tissue, reducing the risk of rejection or adverse reactions.

  • How should the DualX device be stored?

    The DualX device must be stored and handled according to sterile medical device protocols to maintain its sterility. This includes keeping it in its original packaging, away from contamination, and following manufacturer guidelines for shelf life and environmental conditions. Improper storage could compromise the device’s integrity and safety.

  • Is there any MRI safety information provided for the DualX device?

    No MRI safety information is specified for the DualX Interbody Device in the available data. If MRI imaging is required post-surgery, clinicians should consult the device’s packaging or manufacturer for guidance, as some implants may contain metallic components that could interfere with MRI scans or pose safety risks.