510(k) K231808

QUASAR Standalone ACIF System by GS Medical Co., Ltd. — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 20, 2023
Date Received: June 20, 2023
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by GS Medical Co., Ltd.

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K241738 — PYXIS 3D Titanium Cervical Cage system (August 20, 2024)
K240350 — AnyPlus II Spinal Fixation System (April 3, 2024)
K223868 — PYXIS 3D Titanium Cage System (April 26, 2023)
K222041 — CYGNUS-C Standalone ACIF System (February 9, 2023)
K221687 — Pegasus-X Expandable PLIF System (July 27, 2022)
K211797 — TRACKER Plus Kyphoplasty System (October 28, 2021)
K200592 — GS Medical AnyPlus PEEK Cage System (August 10, 2020)
K192335 — TRACKER Kyphoplasty System (December 4, 2019)
K190170 — MVP Cervical Plate System (May 13, 2019)

Other clearances for product code OVE

K260038 — E3D-C Interbody System (February 4, 2026)
K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (December 22, 2025)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K250076 — Endeavor Stand-Alone Cervical IBF System (September 25, 2025)
K250540 — SABER-C System (August 8, 2025)
K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)