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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K260362

510(k) cleared

QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)

MANTIZ Co., Ltd. · Jul 24, 2026 · K260362

FDA cleared the QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) from MANTIZ Co., Ltd. on Jul 24, 2026 under K260362, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 4, 2026. The decision came 170 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for MANTIZ Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260362?

K260362 is the FDA 510(k) for QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration), submitted by MANTIZ Co., Ltd.. FDA's decision date was Jul 24, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)?

MANTIZ Co., Ltd., based in Daegu, is the applicant of record for K260362.

How long did the K260362 review take?

FDA received the submission on Feb 4, 2026 and issued its decision on Jul 24, 2026, 170 days later.

← All decisions in July 2026