DeviceClearance

K141246

Substantially Equivalent

LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM

Applicant
Life Spine, Inc.
Product code
OUR
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hoffman Estates, IL, 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.