DeviceClearance

K180818

Substantially Equivalent

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

Applicant
Tenon Medical, Inc.
Product code
OUR
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Ramon, 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, 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.