Navigation Enabled Instruments— 510(k) K183381

Substantially Equivalent

Stryker

FDA 510(k) clearance K183381 for Navigation Enabled Instruments, Substantially Equivalent on 2019-05-17. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code OLO
Advisory panel: Neurology
Date received: 2018-12-06
Decision date: 2019-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, 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.