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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 / K253559

510(k) cleared

Ventana A Anterior Lumbar Interbody System

Spinal Elements, Inc. · Feb 25, 2026 · K253559

FDA cleared the Ventana A Anterior Lumbar Interbody System from Spinal Elements, Inc. on Feb 25, 2026 under K253559, a traditional 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 17, 2025. The decision came 100 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), K250773 (Luna® Ti Interbody Fusion System).

Questions & Answers

What did FDA clear under K253559?

K253559 is the FDA 510(k) for Ventana A Anterior Lumbar Interbody System, submitted by Spinal Elements, Inc.. FDA's decision date was Feb 25, 2026, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the Ventana A Anterior Lumbar Interbody System?

Spinal Elements, Inc., based in Carlsbad, CA, is the applicant of record for K253559.

How long did the K253559 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Feb 25, 2026, 100 days later.

← All decisions in February 2026

Sources