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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 / September 2025 / K251316

510(k) cleared

Mazor X System / Mazor X Stealth Edition

Mazor Robotics , Ltd. · Sep 11, 2025 · K251316

FDA cleared the Mazor X System / Mazor X Stealth Edition from Mazor Robotics , Ltd. on Sep 11, 2025 under K251316, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 29, 2025. The decision came 135 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 Mazor Robotics , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251316?

K251316 is the FDA 510(k) for Mazor X System / Mazor X Stealth Edition, submitted by Mazor Robotics , Ltd.. FDA's decision date was Sep 11, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Mazor X System / Mazor X Stealth Edition?

Mazor Robotics , Ltd., based in Caeasarea, is the applicant of record for K251316.

How long did the K251316 review take?

FDA received the submission on Apr 29, 2025 and issued its decision on Sep 11, 2025, 135 days later.

← All decisions in September 2025