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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 / October 2025 / K251282

510(k) cleared

StealthStation S8 Spine Software

Medtronic Navigation, Inc. · Oct 17, 2025 · K251282

FDA cleared the StealthStation S8 Spine Software from Medtronic Navigation, Inc. on Oct 17, 2025 under K251282, 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 24, 2025. The decision came 176 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Navigation, Inc. has 4 other decisions in the tracker over the last 12 months: K253379 (Stealth AXiS Cranial clinical application), K253395 (Stealth AXiS ENT clinical application), K253391 (Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)), K253381 (Stealth AXiS Surgical System with Stealth AXiS Spine clinical application).

Questions & Answers

What did FDA clear under K251282?

K251282 is the FDA 510(k) for StealthStation S8 Spine Software, submitted by Medtronic Navigation, Inc.. FDA's decision date was Oct 17, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the StealthStation S8 Spine Software?

Medtronic Navigation, Inc., based in Lafayette, CO, is the applicant of record for K251282.

How long did the K251282 review take?

FDA received the submission on Apr 24, 2025 and issued its decision on Oct 17, 2025, 176 days later.

← All decisions in October 2025