VerteLoc Spinal System— 510(k) K231134

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K231134 for VerteLoc Spinal System, Substantially Equivalent on 2024-02-13. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2023-04-21
Decision date: 2024-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

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.