OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System— 510(k) K252885

Substantially Equivalent

Astura Medical

FDA 510(k) clearance K252885 for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System, Substantially Equivalent on 2026-01-22. Applicant: Astura Medical.

Clearance details

Applicant: Astura Medical
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2025-09-10
Decision date: 2026-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.