FDA.report

510(k) K211163

Device
Bone Cement Genta, Bone Cement HV, Bone Cement LV
Applicant
Tecres S.P.A.
510(k) number
K211163
Product code
LOD
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-09
Date received
2021-04-19
Regulation
888.3027
Classification name
Bone Cement
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Massimo Grazioli
Address
Via Andrea Doria 6 Sommacampagna IT 37066 37066

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code LOD

510(k)DeviceApplicantDecision date
K254107Refobacin Bone Cement R (110034355)Biomet France2026-04-15
K250760SPECTRUM GV Bone CementOsteoremedies, LLC2025-04-02
K241674OSTEOPAL® VHeraeus Medical GmbH2024-12-05
K231556SPECTRUM® GV Bone CementOsteoremedies, LLC2023-12-20
K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda2022-05-31
K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022-05-19
K213812PALACOS MV proHeraeus Medical GmbH2022-02-02
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH2021-07-09
K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH2021-05-18
K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH2021-03-19
K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH2021-03-19
K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GHeraeus Medical GmbH2020-11-23
K193059G1 40 Radiopaque Bone CementG21, S.R.L.2020-03-19
K193061G3 40 Radiopaque Bone CementG21, S.R.L.2020-03-19
K192394Hi-Fatigue Bone CementOsartis GmbH2019-12-02