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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 / January 2026 / K252842

510(k) cleared

SafeOp 3: Neural Informatix System

Alphatec Spine, Inc. · Jan 11, 2026 · K252842

FDA cleared the SafeOp 3: Neural Informatix System from Alphatec Spine, Inc. on Jan 11, 2026 under K252842, a traditional 510(k). The device falls under product code GWF, Stimulator, Electrical, Evoked Response, regulated at 21 CFR 882.1870 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 8, 2025. The decision came 125 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Alphatec Spine, Inc. has 4 other decisions in the tracker over the last 12 months: K261284 (Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System), K253216 (IntraOp Alignment System; CONTOUR3D Bending System), K253615 (Invictus Bands System), K252597 (Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)).

Questions & Answers

What did FDA clear under K252842?

K252842 is the FDA 510(k) for SafeOp 3: Neural Informatix System, submitted by Alphatec Spine, Inc.. FDA's decision date was Jan 11, 2026, under product code GWF (Stimulator, Electrical, Evoked Response).

Who makes the SafeOp 3: Neural Informatix System?

Alphatec Spine, Inc., based in Carlsbad, CA, is the applicant of record for K252842.

How long did the K252842 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Jan 11, 2026, 125 days later.

← All decisions in January 2026