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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 / K252562

510(k) cleared

Spine & Trauma Navigation Instruments

Brainlab AG · Sep 12, 2025 · K252562

FDA cleared the Spine & Trauma Navigation Instruments from Brainlab AG on Sep 12, 2025 under K252562, a special 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 Aug 14, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Brainlab AG has 2 other decisions in the tracker over the last 12 months: K254010 (ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface), K252476 (Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout).

Questions & Answers

What did FDA clear under K252562?

K252562 is the FDA 510(k) for Spine & Trauma Navigation Instruments, submitted by Brainlab AG. FDA's decision date was Sep 12, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Spine & Trauma Navigation Instruments?

Brainlab AG, based in Munich, is the applicant of record for K252562.

How long did the K252562 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Sep 12, 2025, 29 days later.

← All decisions in September 2025

Sources