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LOD — Bone Cement Class II

FDA Device Classification

Classification Details

Product Code
LOD
Device Class
Class II
Regulation Number
888.3027
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250760osteoremediesSPECTRUM GV Bone CementApril 2, 2025
K241674heraeus medicalOSTEOPAL® VDecember 5, 2024
K231556osteoremediesSPECTRUM® GV Bone CementDecember 20, 2023
K211163tecresBone Cement Genta, Bone Cement HV, Bone Cement LVJanuary 9, 2023
K212729biomecanica industria e comerciode produtos ortopedicos ltdaBone Cement-Normal ViscosityMay 31, 2022
K211869ormed grup medikal turizm saglik hizmetleri sanayi veOGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (May 19, 2022
K213812heraeus medicalPALACOS MV proFebruary 2, 2022
K210607heraeus medicalPALACOS R pro, PALACOS R+G pro, PALACOS MV+G proJuly 9, 2021
K202458osartisBonOs Inject, Pedicle screw kits, Cement pusherMay 18, 2021
K210120osartisBonOs HV, BonOs MV, BonOs LVMarch 19, 2021
K210125osartisBonOs HV Genta, BonOs MV Genta, BonOs LV GentaMarch 19, 2021
K202475heraeus medicalPALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GNovember 23, 2020
K193061g21G3 40 Radiopaque Bone CementMarch 19, 2020
K193059g21G1 40 Radiopaque Bone CementMarch 19, 2020
K192394osartisHi-Fatigue Bone CementDecember 2, 2019
K192379osartisHi-Fatigue G Bone CementNovember 27, 2019
K190766heraeus medicalPALACOS fast R+GMay 31, 2019
K181282g21G3A 40 Bone CementJanuary 9, 2019
K182260heraeus medicalPALACOS MVSeptember 17, 2018
K173494g21OrthoSteady G Bone CementMarch 6, 2018