Evolve UniPolar Head— 510(k) K143184

Name: FDA 510(k) clearance K143184
Creator: U.S. Food and Drug Administration
Published: 2015-03-17

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K143184 for Evolve UniPolar Head, Substantially Equivalent on 2015-03-17. Applicant: Signature Orthopaedics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2014-11-05
Decision date: 2015-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

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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.