K162929

Substantially Equivalent

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

Applicant: Stryker Corporation
Product code: HAW
Advisory panel: Neurology
Date received: 2016-10-19
Decision date: 2017-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg Baden-Wurttemberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.