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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 / June 2026 / K253045

510(k) cleared

Socko Vimax Spinal Fixation System

Socko Medical Co., Ltd. · Jun 17, 2026 · K253045

FDA cleared the Socko Vimax Spinal Fixation System from Socko Medical Co., Ltd. on Jun 17, 2026 under K253045, 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 22, 2025. The decision came 268 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 Socko Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253045?

K253045 is the FDA 510(k) for Socko Vimax Spinal Fixation System, submitted by Socko Medical Co., Ltd.. FDA's decision date was Jun 17, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Socko Vimax Spinal Fixation System?

Socko Medical Co., Ltd., based in New Taipei, is the applicant of record for K253045.

How long did the K253045 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 17, 2026, 268 days later.

← All decisions in June 2026