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Staxx Xdl System

by Spine Wave, Inc.

510(k) K102315

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 NumberK102315 Date19 Aug 2011ClearedStatusActive

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  • Withdrawn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
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Staxx Xdl System is a vertebral body replacement device used to replace and restore the height of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine. It is designed to be used with autograft or allograft and supplemental spinal fixation.

The system has a low profile spacer with sizes starting at 8 mm, allowing for easy and less traumatic insertion into the surgical site. It is supplied in various sizes and is intended for use in the thoracolumbar spine, with FDA 510(k) clearance under the reference number K102315.

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Questions

AI-generated answers, 25 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 Staxx Xdl System used for?

    The Staxx Xdl System is used to replace and restore the height of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine, and is designed to be used with autograft or allograft and supplemental spinal fixation.

  • What sizes is the Staxx Xdl System available in?

    The system is supplied in various sizes, starting at 8 mm, allowing for easy and less traumatic insertion into the surgical site.

  • Is the Staxx Xdl System cleared for use in the US?

    Yes, the Staxx Xdl System has FDA 510(k) clearance under the reference number K102315, indicating it is substantially equivalent to a predicate device.