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510(k) K211869

Device
OGM 1 Polymethylmethacrylate (PMMA) Bone Cement, OGM 1A Polymethylmethacrylate (PMMA) Bone Cement
Applicant
Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve
510(k) number
K211869
Product code
LOD  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-19
Date received
2021-06-16
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
No

Applicant Contact#

Contact
Kenan Kara
Address
Ticaret Limited S Macun Mahallesi 177 Cadde No:19 H/7 Timko Is Yerleri Ankara TR 06200 06200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LOD  #

510(k), Device, Applicant table
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
K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.2023-01-09
K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda2022-05-31
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

Legacy Summary#

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FDA Review#

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