Cleared Traditional

iFuse Bedrock Granite? Implant System

K222774 · SI-BONE, Inc. · Orthopedic
Dec 2022
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K222774 is an FDA 510(k) clearance for the iFuse Bedrock Granite? 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 December 22, 2022, 99 days after receiving the submission on September 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K222774 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2022
Decision Date December 22, 2022
Days to Decision 99 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