Cleared Traditional

iFuse Bedrock Granite? Implant System

K233508 · SI-BONE, Inc. · Orthopedic
Jan 2024
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K233508 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 January 26, 2024, 87 days after receiving the submission on October 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233508 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2023
Decision Date January 26, 2024
Days to Decision 87 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