Brisbane ALIF Device, Gladstone ALIF Device— 510(k) K172019

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K172019 for Brisbane ALIF Device, Gladstone ALIF Device, Substantially Equivalent on 2017-11-29. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2017-07-05
Decision date: 2017-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.