Brainlab Compatible K2M Navigation Instruments— 510(k) K192911

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K192911 for Brainlab Compatible K2M Navigation Instruments, Substantially Equivalent on 2019-11-14. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2019-10-15
Decision date: 2019-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View 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, 2020-01-01 through 2026-04-23. 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.