SILEX SACROILIAC JOINT FUSION SYSTEM— 510(k) K140079

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K140079 for SILEX SACROILIAC JOINT FUSION SYSTEM, Substantially Equivalent on 2014-03-25. Applicant: X-Spine Systems, Inc..

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2014-01-13
Decision date: 2014-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, 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.