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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 / K250773

510(k) cleared

Luna® Ti Interbody Fusion System

Spinal Elements, Inc. · Feb 4, 2026 · K250773

FDA cleared the Luna® Ti Interbody Fusion System from Spinal Elements, Inc. on Feb 4, 2026 under K250773, 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 Mar 14, 2025. The decision came 327 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spinal Elements, Inc. has 2 other decisions in the tracker over the last 12 months: K260506 (Ventana® P/T Lumbar Interbody System), K253559 (Ventana A Anterior Lumbar Interbody System).

Questions & Answers

What did FDA clear under K250773?

K250773 is the FDA 510(k) for Luna® Ti Interbody Fusion System, submitted by Spinal Elements, Inc.. FDA's decision date was Feb 4, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Luna® Ti Interbody Fusion System?

Spinal Elements, Inc., based in Carlsbad, CA, is the applicant of record for K250773.

How long did the K250773 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Feb 4, 2026, 327 days later.

← All decisions in February 2026

Sources