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.

Summary

MANTIZ's clearance covers the QUATTRO Spinal system (Open Configuration) and the QUATTRO-GADGET Spinal system (MIS Configuration), filed under NKB, thoracolumbosacral pedicle screw systems. The record doesn't expand "MIS" or list components.

Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

MANTIZ filed from Daegu, South Korea. Review took 170 calendar days (February 4 to July 24, 2026).

Clearance details

Applicant: MANTIZ Co., Ltd.
Product code: Product 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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K262731 — Virata Spinal Fixation System2026-10-29
K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30

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.