ELEOS™

Primary DI
B278PT2000002M0
Brand
ELEOS™
Company
ONKOS SURGICAL, INC.
Model
PT-20000-02M
Catalog number
PT-20000-02M
Device description
ELEOS™ SEGMENTAL PROXIMAL TIBIA WITH BIOGRIP™ POROUS TECHNOLOGY
Published
2021-01-04
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

Related Records

Contact Domains

Product Codes

CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B278PT2000002M0PrimaryHIBCC0

GMDN Terms

TermDefinition
Coated knee tibia prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(844)767-2766customerservice@onkossurgical.com

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B278DVMOD3504N0My3D® Personalized Pelvic ReconstructionDV-MOD35-04N2025-09-22
B278DVRDG3504N0My3D® Personalized Pelvic ReconstructionDV-RGD35-04N2025-09-22
B278AMMS040MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYAM-MS-040MF2024-12-13
B278AMMS050MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYAM-MS-050MF2024-12-13
B278AMMS060MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYAM-MS-060MF2024-12-13
B278AMMS070MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYAM-MS-070MF2024-12-13
B278IMBCEXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimbc/ExSmIMBC-EXSM2024-07-23
B278JTSDFLSTD0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTJTSDF-L-STDJTSDF-L-STD2024-07-23
B278TMKTPEXSM50JTS EXTENDIBLE DISTAL FEMORAL IMPLANTtmktp/ExSm5TMKTP-EXSM52024-07-23
B278IMARDRL0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimardrlIMARDRL2024-07-22
B278IMAXCP0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimaxcpIMAXCP2024-07-22
B278IMBCSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimbc/SmIMBC-SM2024-07-22
B278IMPBIMPEXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/ExSmIMPBIMP-EXSM2024-07-22
B278IMPBIMPSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/SmIMPBIMP-SM2024-07-22
B278JTSDFLSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTJTSDF-L-SMJTSDF-L-SM2024-07-22
B278JTSDFRSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTJTSDF-R-SMJTSDF-R-SM2024-07-22
B278JTSDFRXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTJTSDF-R-XSMJTSDF-R-XSM2024-07-22
B278JTSDRIVEUNIT0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTMLE3JTS-DRIVE-UNIT2024-07-22
B278PIN0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTictjigshPIN2024-07-22

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