POWER-LOAD COT FASTENER SYSTEM— 510(k) K113598

Substantially Equivalent

Stryker Medical

FDA 510(k) clearance K113598 for POWER-LOAD COT FASTENER SYSTEM, Substantially Equivalent on 2011-12-20. Applicant: Stryker Medical.

Clearance details

Applicant: Stryker Medical
Product code: Code FPO
Advisory panel: General Hospital
Date received: 2011-12-05
Decision date: 2011-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

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.