TRACKER Kyphoplasty System— 510(k) K192335

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..

Clearance details

Applicant: GS Medical Co., Ltd.
Product code: Code NDN
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 ↗

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.