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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 / K260506

510(k) cleared

Ventana® P/T Lumbar Interbody System

Spinal Elements, Inc. · May 15, 2026 · K260506

FDA cleared the Ventana® P/T Lumbar Interbody System from Spinal Elements, Inc. on May 15, 2026 under K260506, 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 Feb 17, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Spinal Elements, Inc. has 2 other decisions in the tracker over the last 12 months: K253559 (Ventana A Anterior Lumbar Interbody System), K250773 (Luna® Ti Interbody Fusion System).

Questions & Answers

What did FDA clear under K260506?

K260506 is the FDA 510(k) for Ventana® P/T Lumbar Interbody System, submitted by Spinal Elements, Inc.. FDA's decision date was May 15, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Ventana® P/T Lumbar Interbody System?

Spinal Elements, Inc., based in Carlsbad, CA, is the applicant of record for K260506.

How long did the K260506 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on May 15, 2026, 87 days later.

← All decisions in May 2026

Sources