DOMINION Expandable Corpectomy System— 510(k) K233359

Substantially Equivalent

Astura Medical

FDA 510(k) clearance K233359 for DOMINION Expandable Corpectomy System, Substantially Equivalent on 2024-03-08. Applicant: Astura Medical.

Clearance details

Applicant: Astura Medical
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2023-09-29
Decision date: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.