Home GUDID B278AM25002200C0 ELEOS™ Limb Salvage System with NanoCept® Technology
Primary DI B278AM25002200C0
Brand ELEOS™ Limb Salvage System with NanoCept® Technology
Company ONKOS SURGICAL, INC.
Model AM-25002200-C
Catalog number AM-25002200-C
Device description ELEOS™ Limb Salvage System with NanoCept® Technology Antibacterial Coated Proximal Tibia
Published 2026-06-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic 2 QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B278AM25002200C0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rotating hinged total knee prosthesis A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not re-use Special Storage Condition, Specify 0 0 Do not use if package is damaged Special Storage Condition, Specify 0 0 Keep away from rain Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Temperature limit
Regulatory Flags# DUNS number 080254074 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B278IMPBIMPEXSM0 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT impbimp/ExSm IMPBIMP-EXSM 2024-07-22 B278IMPBIMPSM0 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT impbimp/Sm IMPBIMP-SM 2024-07-22 B278IMGENIMP0 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT imgenimp IMGENIMP 2024-07-19 B278IMPBIMPSTD0 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT impbimp/Std IMPBIMP-STD 2024-07-19 B278HDSP03604N0 My3D® Personalized Pelvic Reconstruction DG-SP036-04N DG-SP036-04N 2023-02-22 B278IMCIRPR0 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT imcirpr IMCIRPR 2024-07-19 B278HC1112003M0 ELEOS Limb Salvage System With BioGrip HC-11120-03M HC-11120-03M 2021-06-30 B278HC1312003M0 ELEOS Limb Salvage System With BioGrip HC-13120-03M HC-13120-03M 2021-06-30 B278HC1512003M0 ELEOS Limb Salvage System With BioGrip HC-15120-03M HC-15120-03M 2021-06-30 B278HC1712003M0 ELEOS Limb Salvage System With BioGrip HC-17120-03M HC-17120-03M 2021-06-30 B278DV3500004N0 My3D® Personalized Pelvic Reconstruction DV-35000-04N 2025-09-22 B278DVMOD3504N0 My3D® Personalized Pelvic Reconstruction DV-MOD35-04N 2025-09-22 B278DVRDG3504N0 My3D® Personalized Pelvic Reconstruction DV-RGD35-04N 2025-09-22 B278PINS0 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT ibnpin PINS 2024-07-22 B278LS5001804M0 My3D® Personalized Pelvic Reconstruction LS-50018-04M 2024-03-11 B278LS5004604M0 My3D® Personalized Pelvic Reconstruction LS-50046-04M 2024-03-11 B278LS5002004M0 My3D® Personalized Pelvic Reconstruction LS-50020-04M 2024-03-08 B278LS5002204M0 My3D® Personalized Pelvic Reconstruction LS-50022-04M 2024-03-08 B278LS5002404M0 My3D® Personalized Pelvic Reconstruction LS-50024-04M 2024-03-08 B278LS5002504M0 My3D® Personalized Pelvic Reconstruction LS-50025-04M 2024-03-08
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