Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments— 510(k) K190172

Substantially Equivalent

Stryker

FDA 510(k) clearance K190172 for Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments, Substantially Equivalent on 2019-06-14. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code HBE
Advisory panel: Neurology
Date received: 2019-02-01
Decision date: 2019-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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.