QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)— 510(k) K260362

Name: FDA 510(k) clearance K260362
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

MANTIZ Co., Ltd.

FDA 510(k) clearance K260362 for QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration), Substantially Equivalent on 2026-07-24. Applicant: MANTIZ Co., Ltd.. Device class: 2.

Clearance details

Applicant: MANTIZ Co., Ltd.
Product code: Code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2026-02-04
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

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K253943 — Tiger 2 System2026-07-24
K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01
K253045 — Socko Vimax Spinal Fixation System2026-06-17
K251251 — ChanPin Pedicle Screw Spinal System2026-06-09

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.