Cleared Special

iFuse Implant System?

K182983 · SI-BONE, Inc. · Orthopedic
Nov 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K182983 is an FDA 510(k) clearance for the iFuse Implant System?, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on November 27, 2018, 29 days after receiving the submission on October 29, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K182983 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2018
Decision Date November 27, 2018
Days to Decision 29 days
Submission Type Special
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