DeviceClearance

CoreLink Navigation Instruments— 510(k) K230880

Substantially Equivalent

Corelink, LLC

FDA 510(k) clearance K230880 for CoreLink Navigation Instruments, Substantially Equivalent on 2023-05-02. Applicant: Corelink, LLC.

Clearance details

Applicant
Corelink, LLC
Product code
Code OLO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
St. Louis, MO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

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.