Cleared Traditional

iFuse Implant System(R)

K152681 · SI-BONE, Inc. · Orthopedic
Mar 2016
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K152681 is an FDA 510(k) clearance for the iFuse Implant System(R), a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SI-BONE, Inc. (San Jose, US). The FDA issued a Cleared decision on March 1, 2016, 165 days after receiving the submission on September 18, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K152681 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2015
Decision Date March 01, 2016
Days to Decision 165 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