FDA.reportPublic FDA data

ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY

Primary DI
B278AMMS070MF0
Brand
ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY
Company
ONKOS SURGICAL, INC.
Model
AM-MS-070MF
Device description
ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 70MM
Published
2024-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QZZLimb And Joint Salvage Device With Coating For Bacteria Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZZLimb And Joint Salvage Device With Coating For Bacteria ReductionOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210058000ELEOSx™ Limb Salvage SystemOnkos Surgical2024-04-05QZZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B278AMMS070MF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Body femoral/tibial extension stem, coatedA sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080254074
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B278IMPBIMPEXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/ExSmIMPBIMP-EXSM2024-07-22
B278IMPBIMPSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/SmIMPBIMP-SM2024-07-22
B278IMGENIMP0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimgenimpIMGENIMP2024-07-19
B278IMPBIMPSTD0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/StdIMPBIMP-STD2024-07-19
B278HDSP03604N0My3D® Personalized Pelvic Reconstruction DG-SP036-04NDG-SP036-04N2023-02-22
B278IMCIRPR0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimcirprIMCIRPR2024-07-19
B278HC1112003M0ELEOS Limb Salvage System With BioGripHC-11120-03M HC-11120-03M 2021-06-30
B278HC1312003M0ELEOS Limb Salvage System With BioGripHC-13120-03M HC-13120-03M 2021-06-30
B278HC1512003M0ELEOS Limb Salvage System With BioGripHC-15120-03M HC-15120-03M 2021-06-30
B278HC1712003M0ELEOS Limb Salvage System With BioGripHC-17120-03M HC-17120-03M 2021-06-30
B278DV3500004N0My3D® Personalized Pelvic ReconstructionDV-35000-04N2025-09-22
B278DVMOD3504N0My3D® Personalized Pelvic ReconstructionDV-MOD35-04N2025-09-22
B278DVRDG3504N0My3D® Personalized Pelvic ReconstructionDV-RGD35-04N2025-09-22
B278PINS0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTibnpinPINS2024-07-22
B278LS5001804M0My3D® Personalized Pelvic Reconstruction LS-50018-04M2024-03-11
B278LS5004604M0My3D® Personalized Pelvic Reconstruction LS-50046-04M2024-03-11
B278LS5002004M0My3D® Personalized Pelvic Reconstruction LS-50020-04M2024-03-08
B278LS5002204M0My3D® Personalized Pelvic Reconstruction LS-50022-04M2024-03-08
B278LS5002404M0My3D® Personalized Pelvic Reconstruction LS-50024-04M2024-03-08
B278LS5002504M0My3D® Personalized Pelvic Reconstruction LS-50025-04M2024-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B278AMMS040MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYONKOS SURGICAL, INC.QZZ2024-12-13
B278AMMS050MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYONKOS SURGICAL, INC.QZZ2024-12-13
B278AMMS060MF0ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGYONKOS SURGICAL, INC.QZZ2024-12-13