DeviceClearance

Brainlab Compatible K2M Navigation Instruments— 510(k) K181890

Substantially Equivalent

K2m

FDA 510(k) clearance K181890 for Brainlab Compatible K2M Navigation Instruments, Substantially Equivalent on 2018-11-09. Applicant: K2m.

Clearance details

Applicant
K2m
Product code
Code OLO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Leesburg, VA, 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.