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Leva Spacer System

by Spine Wave, Inc.

510(k) K141980

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 NumberK141980 Date26 Jan 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  • Withdrawn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)

Full name
Leva (Tm) Spacer System
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, 27 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 Leva Spacer System is an intervertebral body fusion device for lumbar spine surgery. It is designed to provide segmental stabilization, restore disc height, and feature a unique open architecture for bone graft placement.

The device is available in fixed and expandable configurations, with the expandable version inserted in a collapsed state and expanded in situ via mechanical means. It is supplied non-sterile and intended for single-use implantation in a surgical setting under physician direction.

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Questions

AI-generated answers, 27 Sep 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 LEVA Spacer System used for in lumbar spine surgery?

    The LEVA Spacer System is an intervertebral body fusion device designed to provide segmental stabilization and restore disc height in lumbar spine surgery. It features a unique open architecture that facilitates bone graft placement.

  • How is the LEVA Spacer System supplied and what is its intended use?

    The LEVA Spacer System is supplied non-sterile and is intended for single-use implantation in a surgical setting under physician direction. It comes in both fixed and expandable configurations to meet different surgical needs.

  • What are the available configurations of the LEVA Spacer System?

    The LEVA Spacer System is available in fixed and expandable configurations. The expandable version is inserted in a collapsed state and can be expanded in situ through mechanical means, allowing for precise placement during surgery.

  • What is the regulatory status of the LEVA Spacer System?

    The LEVA Spacer System has received FDA 510(k) clearance with a decision code of SESE (Substantially Equivalent) and was reviewed by the Orthopedic advisory committee. It is classified under product code MAX.