EQUESTRA FLUID DELIVERY SYSTEM— 510(k) K043568

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K043568 for EQUESTRA FLUID DELIVERY SYSTEM, Substantially Equivalent on 2005-01-25. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2004-12-27
Decision date: 2005-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.