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Ellipse Magec Spinal Bracing and Distraction System

by Ellipse Technologies, Inc.

510(k) K140178

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140178 Date27 Feb 2014ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0528-2022 FDA Class II initiated 25 Jun 2019

    Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

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  • Withdrawn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
PGN
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Ellipse Magec Spinal Bracing and Distraction System is a growing rod system with magnetic actuation. It is designed to provide spinal bracing and distraction for patients requiring orthopedic intervention.

This device is regulated under FDA 510K clearance. It is classified as a class 2 medical device under regulation number 888.3070.

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