DeviceClearance

K241813

Substantially Equivalent

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Applicant
Si-Technology, LLC
Product code
OUR
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Collins, CO, 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, through . 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.