Cleared Traditional

REUNION Sacroiliac Joint Fusion System

K232211 · Astura Medical · Orthopedic
Oct 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K232211 is an FDA 510(k) clearance for the REUNION Sacroiliac Joint Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on October 24, 2023, 90 days after receiving the submission on July 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K232211 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2023
Decision Date October 24, 2023
Days to Decision 90 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