Cleared Traditional

iFuse Bedrock Granite? Implant System

K220195 · SI-BONE, Inc. · Orthopedic
May 2022
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K220195 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 May 26, 2022, 122 days after receiving the submission on January 24, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K220195 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2022
Decision Date May 26, 2022
Days to Decision 122 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