Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range— 510(k) K200043

Substantially Equivalent

Field Orthopaedics Pty, Ltd.

FDA 510(k) clearance K200043 for Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range, Substantially Equivalent on 2020-03-23. Applicant: Field Orthopaedics Pty, Ltd..

Clearance details

Applicant: Field Orthopaedics Pty, Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2020-01-08
Decision date: 2020-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring Hill, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.