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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 / K250894

510(k) cleared

Eminent Spine Posterior SI System

Eminent Spine · Oct 7, 2025 · K250894

FDA cleared the Eminent Spine Posterior SI System from Eminent Spine on Oct 7, 2025 under K250894, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 25, 2025. The decision came 196 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 Eminent Spine in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250894?

K250894 is the FDA 510(k) for Eminent Spine Posterior SI System, submitted by Eminent Spine. FDA's decision date was Oct 7, 2025, under product code OUR (Sacroiliac Joint Fixation).

Who makes the Eminent Spine Posterior SI System?

Eminent Spine, based in Plano, TX, is the applicant of record for K250894.

How long did the K250894 review take?

FDA received the submission on Mar 25, 2025 and issued its decision on Oct 7, 2025, 196 days later.

← All decisions in October 2025