Cleared Traditional

SI-FIX SACROILIAC JOINT FUSION SYSTEM

K110472 · Medtronic Sofamor Danek · Orthopedic
May 2012
Decision
466d
Days
Class 2
Risk

About This 510(k) Submission

K110472 is an FDA 510(k) clearance for the SI-FIX SACROILIAC JOINT FUSION SYSTEM, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on May 29, 2012, 466 days after receiving the submission on February 18, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K110472 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2011
Decision Date May 29, 2012
Days to Decision 466 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