K210377

Substantially Equivalent

Stryker iBur hubs and cutting accessories

Applicant: Stryker Corporation
Product code: HBE
Advisory panel: Neurology
Date received: 2021-02-09
Decision date: 2021-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.