Cleared Traditional

Eminent Spine Posterior SI System

K250894 · Eminent Spine · Orthopedic
Oct 2025
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K250894 is an FDA 510(k) clearance for the Eminent Spine Posterior SI System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Eminent Spine (Plano, US). The FDA issued a Cleared decision on October 7, 2025, 196 days after receiving the submission on March 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250894 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2025
Decision Date October 07, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion