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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 / May 2026 / K253894

510(k) cleared

BMD Titanium Spinal Fusion System

Global Biomedica s.r.o. · May 28, 2026 · K253894

FDA cleared the BMD Titanium Spinal Fusion System from Global Biomedica s.r.o. on May 28, 2026 under K253894, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 4, 2025. The decision came 175 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 Global Biomedica s.r.o. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253894?

K253894 is the FDA 510(k) for BMD Titanium Spinal Fusion System, submitted by Global Biomedica s.r.o.. FDA's decision date was May 28, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the BMD Titanium Spinal Fusion System?

Global Biomedica s.r.o., based in Ceský Teín, is the applicant of record for K253894.

How long did the K253894 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on May 28, 2026, 175 days later.

← All decisions in May 2026