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510(k) K123081

Device
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
Applicant
AAP BIOMATERIALS GMBH & CO. KG
510(k) number
K123081
Product code
LOD  
Decision
Substantially Equivalent (SESE)
Decision date
2013-03-07
Date received
2012-10-01
Regulation
888.3027
Classification name
Bone Cement
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VOLKER STIRNAL
Address
Lagerstrasse 11-15 Dieburg DE 64807 64807

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
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

Legacy Summary#

summary

FDA Review#

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