DeviceClearance

K051293

Substantially Equivalent

CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM

Applicant
Ceremed , Inc.
Product code
JEY
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY
Injury
1,542
Malfunction
2,292
Total
3,834

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.