NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System— 510(k) K143134

Substantially Equivalent

Cossington, Ltd.

FDA 510(k) clearance K143134 for NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System, Substantially Equivalent on 2015-03-05. Applicant: Cossington, Ltd..

Clearance details

Applicant: Cossington, Ltd.
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2014-10-31
Decision date: 2015-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston Upon Thames, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.