FDA.report

ELEOS Limb Salvage System With BioGrip

Primary DI
B278HYRULDF03N0
Brand
ELEOS Limb Salvage System With BioGrip
Company
ONKOS SURGICAL, INC.
Model
HY-RULDF-03N
Catalog number
HY-RULDF-03N
Device description
ELEOS Distal Femur Collar Resection Template
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B278HYRULDF03N0PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam 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
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

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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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