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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 / October 2025 / K252730

510(k) cleared

Fule Spinal Fixation System

Beijing Fule Science & Technology Development Co., Ltd. · Oct 24, 2025 · K252730

FDA cleared the Fule Spinal Fixation System from Beijing Fule Science & Technology Development Co., Ltd. on Oct 24, 2025 under K252730, 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 57 days later, inside the 90 FDA-day goal for a 510(k).

Beijing Fule Science & Technology Development Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K253155 (Fule Metallic Lockable Intramedullary Nail Systems), K253151 (Fule Interbody Fusion Cage System).

Questions & Answers

What did FDA clear under K252730?

K252730 is the FDA 510(k) for Fule Spinal Fixation System, submitted by Beijing Fule Science & Technology Development Co., Ltd.. FDA's decision date was Oct 24, 2025, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Fule Spinal Fixation System?

Beijing Fule Science & Technology Development Co., Ltd., based in Beijing, is the applicant of record for K252730.

How long did the K252730 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Oct 24, 2025, 57 days later.

← All decisions in October 2025

Sources