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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 / February 2026 / K253169

510(k) cleared

Duet Spinal Fixation System

Box Spine, LLC · Feb 23, 2026 · K253169

FDA cleared the Duet Spinal Fixation System from Box Spine, LLC on Feb 23, 2026 under K253169, 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 Sep 26, 2025. The decision came 150 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 Box Spine, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253169?

K253169 is the FDA 510(k) for Duet Spinal Fixation System, submitted by Box Spine, LLC. FDA's decision date was Feb 23, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Duet Spinal Fixation System?

Box Spine, LLC, based in Tulsa, OK, is the applicant of record for K253169.

How long did the K253169 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Feb 23, 2026, 150 days later.

← All decisions in February 2026