Cleared Traditional

Liberty SI Lateral Implant System

K231923 · Spinal Simplicity, LLC · Orthopedic
Dec 2023
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K231923 is an FDA 510(k) clearance for the Liberty SI Lateral Implant System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on December 5, 2023, 158 days after receiving the submission on June 30, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231923 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2023
Decision Date December 05, 2023
Days to Decision 158 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