Skip to content

Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System

by Ebi, L.P.

510(k) K100438

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 NumberK100438 Date23 Jun 2010ClearedStatusActive

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  • Withdrawn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, 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 Polaris Spinal System is a non-cervical spinal fixation system that provides immobilization and stabilization as an adjunct to fusion. System components include stainless steel dominoes, washers, pedicle screws, hooks, sacral/iliac screws, and rods. It is used in posterior, anterior, or anterolateral spinal surgery and supports percutaneous and minimally invasive approaches.

The device is supplied for use in clinical settings by surgeons for spinal stabilization, providing mechanical fixation of spinal segments to promote fusion and alleviate symptoms of degenerative conditions, trauma, or deformity. Domino components allow connection between Polaris and other systems (Altius, Array, Omega21, Synergy) for multi-level fixation. The device has FDA 510K clearance with product code NKB.

Other devices from Ebi, L.P.

See all devices from Ebi, L.P. →

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 Polaris Spinal System used for?

    The Polaris Spinal System is a non-cervical spinal fixation system that provides immobilization and stabilization as an adjunct to fusion in posterior, anterior, or anterolateral spinal surgery. It supports percutaneous and minimally invasive approaches and is used to treat degenerative conditions, trauma, or deformity.

  • What components are included in the Polaris Spinal System?

    System components include stainless steel dominoes, washers, pedicle screws, hooks, sacral/iliac screws, and rods. Domino components allow connection between Polaris and other systems (Altius, Array, Omega21, Synergy) for multi-level fixation.

  • Is the Polaris Spinal System cleared for use in the United States?

    Yes, the Polaris Spinal System has FDA 510K clearance with product code NKB. It was received by the FDA on February 17, 2010, and cleared on June 23, 2010, with a decision code of SESE (Substantially Equivalent).

  • How is the Polaris Spinal System supplied?

    The device is supplied for use in clinical settings by surgeons for spinal stabilization. It provides mechanical fixation of spinal segments to promote fusion and alleviate symptoms of various spinal conditions.