Bony Trauma Extremity System (BTES) Screw Range, NX Nail— 510(k) K230118

Name: FDA 510(k) clearance K230118
Creator: U.S. Food and Drug Administration
Published: 2023-02-16

Substantially Equivalent

Field Orthopaedics Pty, Ltd.

FDA 510(k) clearance K230118 for Bony Trauma Extremity System (BTES) Screw Range, NX Nail, Substantially Equivalent on 2023-02-16. Applicant: Field Orthopaedics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Field Orthopaedics Pty, Ltd.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2023-01-17
Decision date: 2023-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Teneriffe, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.