Freedom Posterior Cervical Screws— 510(k) K242674

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K242674 for Freedom Posterior Cervical Screws, Substantially Equivalent on 2025-05-13. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2024-09-06
Decision date: 2025-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.