FDA.reportPublic FDA data

ELEOS Limb Salvage System With BioGrip

Primary DI
B278PL0001003N0
Brand
ELEOS Limb Salvage System With BioGrip
Company
ONKOS SURGICAL, INC.
Model
PL-00010-03N
Catalog number
PL-00010-03N
Device description
ELEOS Cortical Planer Modular Guide Stem, 10mm
Published
2021-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B278PL0001003N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
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
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B278DV3500004N0My3D® Personalized Pelvic ReconstructionDV-35000-04N2025-09-22
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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