40-42mm BiPolar Head and 22mm Femoral Head— 510(k) K163081

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K163081 for 40-42mm BiPolar Head and 22mm Femoral Head, Substantially Equivalent on 2018-01-29. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2016-11-03
Decision date: 2018-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.