iFuse Bedrock Granite Implant System— 510(k) K220195

Name: FDA 510(k) clearance K220195
Creator: U.S. Food and Drug Administration
Published: 2022-05-26

Substantially Equivalent

SI-BONE, Inc.

FDA 510(k) clearance K220195 for iFuse Bedrock Granite Implant System, Substantially Equivalent on 2022-05-26. Applicant: SI-BONE, Inc.. Device class: 2.

Clearance details

Applicant: SI-BONE, Inc.
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2022-01-24
Decision date: 2022-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

More clearances from SI-BONE, Inc.

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K253094 — iFuse Bedrock Granite Implant System2025-10-09
K251780 — iGPS Navigation Instruments2025-09-15
K241504 — iFuse TORQ TNT Implant System2024-08-19
K241574 — iFuse TORQ® Implant System2024-07-02
K232800 — Navigation Tracking Instruments2024-02-23

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.