Skip to content

QUASAR Standalone ACIF System

by GS Medical Co., Ltd.

510(k) K231808

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 NumberK231808 Date20 Jul 2023ClearedStatusActive

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  • Withdrawn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
OVE
Device class
Class II
Regulation
21 CFR Part 888.3080
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 QUASAR Standalone ACIF System is an orthopedic device designed for standalone anterior cervical interbody fusion procedures. It is intended to provide stabilization and promote fusion in the cervical spine.

The system is supplied by GS Medical Co., Ltd. and received FDA 510(k) clearance with decision code SESE on July 20, 2023. It is categorized under product code OVE and was reviewed by the Orthopedic advisory committee. The device is available in various sizes as indicated by the model number K231808.

Other devices from GS Medical Co., Ltd.

See all devices from GS Medical Co., Ltd. →

Questions

AI-generated answers, 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.

  • What is the QUASAR Standalone ACIF System used for?

    The QUASAR Standalone ACIF System is an orthopedic device designed for standalone anterior cervical interbody fusion procedures. It provides stabilization and promotes fusion in the cervical spine.

  • How is the QUASAR Standalone ACIF System supplied?

    The system is supplied by GS Medical Co., Ltd. and is available in various sizes as indicated by the model number K231808. The specific packaging and contents would be detailed in the product instructions.

  • What regulatory status does the QUASAR Standalone ACIF System have?

    The QUASAR Standalone ACIF System received FDA 510(k) clearance with decision code SESE on July 20, 2023. It is categorized under product code OVE and was reviewed by the Orthopedic advisory committee.

  • Is the QUASAR Standalone ACIF System reusable or single-use?

    The device data does not specify whether the QUASAR Standalone ACIF System is designed for single-use or multiple reuse. This information would be detailed in the product instructions and labeling provided by the manufacturer.