PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw— 510(k) K230655

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K230655 for PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw, Substantially Equivalent on 2023-05-03. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2023-03-09
Decision date: 2023-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.