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Modification to Beacon Stabilization System

by Globus Medical, Inc.

510(k) K092610

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 · Special NumberK092610 Date24 Sep 2009ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a modification to the Beacon Stabilization System, which is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments. It is classified under product code NKB and falls within the orthopedic medical specialty.

The device received FDA 510(k) clearance (K092610) on September 24, 2009, as substantially equivalent to a predicate device. It is supplied as a non-sterile, reusable system for use in orthopedic spinal stabilization procedures, with no indication of MRI safety or single-use designation provided in the data.

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Questions

AI-generated answers, 28 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 Modification to Beacon Stabilization System used for?

    It is intended to provide immobilization and stabilization of spinal segments as part of a thoracolumbosacral pedicle screw system, used in orthopedic spinal stabilization procedures to support spinal fusion or trauma treatment.

  • Is the Modification to Beacon Stabilization System sterile or single-use?

    The device is supplied as non-sterile and reusable, meaning it must be cleaned and sterilized by the healthcare facility before each use; it is not designed for single-use application.

  • How was the Modification to Beacon Stabilization System cleared for market?

    It received FDA 510(k) clearance under K092610 on September 24, 2009, as substantially equivalent to a predicate device, based on its technological characteristics and intended use.