Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner— 510(k) K153131

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K153131 for Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner, Substantially Equivalent on 2016-06-03. Applicant: Signature Orthopaedics Pty, Ltd..

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2015-10-30
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.