iFuse Implant System®— 510(k) K182983

Substantially Equivalent

SI-BONE, Inc.

FDA 510(k) clearance K182983 for iFuse Implant System®, Substantially Equivalent on 2018-11-27. Applicant: SI-BONE, Inc..

Clearance details

Applicant: SI-BONE, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2018-10-29
Decision date: 2018-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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.