Skip to content

NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System

by Nu Vasive, Incorporated

510(k) K151374

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 NumberK151374 Date6 Aug 2015ClearedStatusActive

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  • Withdrawn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 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System and NuVasive AP Expandable XLIF System are expandable interbody fusion devices designed for lumbar spine surgery. These systems are classified as expandable interbody cages intended for intervertebral body fusion in skeletally mature patients, providing structural support and facilitating spinal stabilization. The devices are engineered to accommodate bone graft material, including autogenous or allogeneic cancellous and corticocancellous bone, to promote fusion between vertebral bodies. Their expandable design allows for precise sizing and placement within the intervertebral space, enhancing surgical flexibility and outcomes.

The systems are supplied sterile and intended for single-use. They are regulated under the FDA’s 510(k) clearance process, classified under the Orthopedic advisory committee with a Traditional review pathway. The devices are available in various sizes and configurations to accommodate different anatomical requirements. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to surgical use. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Other devices from Nu Vasive, Incorporated

See all devices from Nu Vasive, Incorporated →

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 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System used for?

    This system is designed for lumbar spine surgery to facilitate intervertebral body fusion in skeletally mature patients. The expandable interbody cages provide structural support between vertebral bodies while accommodating bone graft material—such as autogenous or allogeneic cancellous or corticocancellous bone—to promote fusion. The adjustable design allows for tailored sizing and placement within the intervertebral space, improving surgical adaptability and outcomes.

  • How are the NuVasive MLX-Medial and AP Expandable XLIF Systems supplied?

    Both systems are supplied sterile and intended for single-use only. This ensures sterility and safety during surgery, reducing the risk of contamination. The devices are packaged and handled according to sterile medical device protocols to maintain integrity until use.

  • Are these devices reusable or single-use?

    These devices are explicitly designed for single-use only. The expandable interbody cage systems are not intended for reprocessing or reuse, as this could compromise sterility and structural integrity. Adherence to single-use guidelines ensures patient safety and compliance with regulatory standards.

  • What sizes and configurations are available for these systems?

    The NuVasive MLX-Medial Lateral and AP Expandable XLIF Systems come in various sizes and configurations to accommodate different anatomical requirements. The expandable design allows for precise sizing within the intervertebral space, ensuring a tailored fit for the patient’s specific lumbar spine anatomy. Exact dimensions and models should be referenced in the product documentation for surgical planning.

  • How should these devices be stored before use?

    Storage must comply with sterile medical device protocols to preserve the integrity of the devices. They should be kept in their original, sealed packaging until immediately before use, protected from contamination, moisture, and physical damage. Follow manufacturer guidelines for shelf-life and handling to ensure optimal performance during surgery.