Bone Cement Genta, Bone Cement HV, Bone Cement LV— 510(k) K211163

Substantially Equivalent

Tecres S.P.A.

FDA 510(k) clearance K211163 for Bone Cement Genta, Bone Cement HV, Bone Cement LV, Substantially Equivalent on 2023-01-09. Applicant: Tecres S.P.A..

Clearance details

Applicant: Tecres S.P.A.
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2021-04-19
Decision date: 2023-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sommacampagna, IT

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.