NP Cement HV Genta; NP Cement LV Genta; NP Cement HV System Genta; NP Cement LV System Genta— 510(k) K143100

Name: FDA 510(k) clearance K143100
Creator: U.S. Food and Drug Administration
Published: 2015-03-05

Substantially Equivalent

Cossington, Ltd.

FDA 510(k) clearance K143100 for NP Cement HV Genta; NP Cement LV Genta; NP Cement HV System Genta; NP Cement LV System Genta, Substantially Equivalent on 2015-03-05. Applicant: Cossington, Ltd.. Device class: 2.

Clearance details

Device name as filed: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta
Applicant: Cossington, Ltd.
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2014-10-28
Decision date: 2015-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston Upon Thames, GB

Download summary PDF View on FDA.gov ↗

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K143134 — NP Cement HV; NP Cement LV; NP Cement HV System; NP Cement LV System2015-03-05

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.