STRYKER DISPOSABLE CRANIAL PERFORATOR BIT— 510(k) K082010

Substantially Equivalent

Stryker Ireland Ltd., Instruments Division

FDA 510(k) clearance K082010 for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT, Substantially Equivalent on 2008-12-29. Applicant: Stryker Ireland Ltd., Instruments Division.

Clearance details

Applicant: Stryker Ireland Ltd., Instruments Division
Product code: Code HBF
Advisory panel: Neurology
Date received: 2008-07-15
Decision date: 2008-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrigtwohill, Co.Cork, IE

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Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.