TRACKER Kyphoplasty System— 510(k) K192335

Name: FDA 510(k) clearance K192335
Creator: U.S. Food and Drug Administration
Published: 2019-12-04

Substantially Equivalent

GS Medical Co., Ltd.

FDA 510(k) clearance K192335 for TRACKER Kyphoplasty System, Substantially Equivalent on 2019-12-04. Applicant: GS Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: GS Medical Co., Ltd.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2019-08-28
Decision date: 2019-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osong-Eup, Cheongwon-Gun, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NDN

view all

K251896 — XeliteMed SuperM-Fix Spinal Bone Cement2026-01-28
K250637 — VCFix Spinal System2025-05-30
K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System2025-04-11
K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement2024-09-18
K232842 — Balloon Inflation System2024-02-29

More clearances from GS Medical Co., Ltd.

view all

K243073 — AnyPlus Navigated Instruments System2024-12-06
K241738 — PYXIS 3D Titanium Cervical Cage system2024-08-20
K240350 — AnyPlus II Spinal Fixation System2024-04-03
K231808 — QUASAR Standalone ACIF System2023-07-20
K223868 — PYXIS 3D Titanium Cage System2023-04-26

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.