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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 / November 2025 / K252729

510(k) cleared

Universal Spinal System

Double Medical Technology, Inc. · Nov 18, 2025 · K252729

FDA cleared the Universal Spinal System from Double Medical Technology, Inc. on Nov 18, 2025 under K252729, 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 Aug 28, 2025. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Double Medical Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252729?

K252729 is the FDA 510(k) for Universal Spinal System, submitted by Double Medical Technology, Inc.. FDA's decision date was Nov 18, 2025, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Universal Spinal System?

Double Medical Technology, Inc., based in Xiamen, is the applicant of record for K252729.

How long did the K252729 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Nov 18, 2025, 82 days later.

← All decisions in November 2025