K143184

Substantially Equivalent

Evolve UniPolar Head

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: KWL
Advisory panel: Orthopedic
Date received: 2014-11-05
Decision date: 2015-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.