K233989

Substantially Equivalent

CarboClear® Posterior Cervical Screw System

Applicant
CarboFix Orthopedics , Ltd.
Product code
NKG
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Herzeliya, IL
Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG
Death
15
Injury
1,090
Malfunction
529
Total
1,634

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.