FDA.report

510(k) K250760

Device
SPECTRUM GV Bone Cement
Applicant
Osteoremedies, LLC
510(k) number
K250760
Product code
LOD
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-02
Date received
2025-03-13
Regulation
888.3027
Classification name
Bone Cement
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Rachel Kennedy
Address
6800 Poplar Ave. Suite 120 Memphis TN US 38138 38138

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
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
K192394Hi-Fatigue Bone CementOsartis GmbH2019-12-02