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

Name: FDA 510(k) clearance K211163
Creator: U.S. Food and Drug Administration
Published: 2023-01-09

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.. Device class: 2.

Clearance details

Applicant: Tecres S.P.A.
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
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 ↗

Recent devices under product code LOD

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K254107 — Refobacin Bone Cement R (110034355)2026-04-15
K250760 — SPECTRUM GV Bone Cement2025-04-02
K241674 — OSTEOPAL® V2024-12-05
K231556 — SPECTRUM® GV Bone Cement2023-12-20
K212729 — Bone Cement-Normal Viscosity2022-05-31

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K252326 — InterSpace GV Hip Spacer2025-08-06
K220131 — KYPHON VuE Bone Cement2022-04-18
K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS2019-04-27
K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM2013-03-28
K112983 — SPACER-S2011-12-12

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.