JTS EXTENDIBLE DISTAL FEMORAL IMPLANT SMTBC02G

GUDID B278SMTBC02G0

Tibial Rotationg Hinge Passive Bearing STD

ONKOS SURGICAL, INC.

Uncoated knee tibia prosthesis, metallic
Primary Device IDB278SMTBC02G0
NIH Device Record Keyed76a7fe-be4f-4a7a-bf92-9eb4dc16617d
Commercial Distribution StatusIn Commercial Distribution
Brand NameJTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Version Model NumberSMTBC02G
Catalog NumberSMTBC02G
Company DUNS080254074
Company NameONKOS SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS105060296232832 [Previous]
HIBCCB278SMTBC02G0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

On-Brand Devices [JTS EXTENDIBLE DISTAL FEMORAL IMPLANT]

B278TMKTPSTD5R0Trial Tibial Plateau Plate: 5mm Standard
B278TMKTPSTD20R0Trial Tibial Plateau Plate: 20mm Standard
B278TMKTPSTD15R0Trial Tibial Plateau Plate: 15mm Standard
B278TMKTPSTD10R0Trial Tibial Plateau Plate: 10mm Standard
B278TMKTPSM5R0Trial Tibial Plateau Plate: 5mm Small
B278TMKTPSM20R0Trial Tibial Plateau Plate: 20mm Small
B278TMKTPSM15R0Trial Tibial Plateau Plate: 15mm Small
B278TMKTPSM10R0Trial Tibial Plateau Plate: 10mm Small
B278TMKTPEXSM200Trial Tibial Plateau Plate: 20mm Extra-Small
B278TMKTPEXSM150Trial Tibial Plateau Plate: 15mm Extra-Small
B278TMKTPEXSM100Trial Tibial Plateau Plate: 10mm Extra-Small
B278SMMLTBC000Tibial Rotating Hinge Metal Cased Bearing XSM
B278SMMLTB020Tibial Rotating Hinge Metal Cased Bearing STD
B278SMMLTB010Tibial Rotating Hinge Metal Cased Bearing SM
B278SMLTBC020Tibial Rotating Hinge Poly Cased Bearing STD
B278SMLTBC010Tibial Rotating Hinge Poly Cased Bearing SM
B278SMLTBC000Tibial Rotating Hinge Poly Cased Bearing XSM
B278SMBPR020Bumper Pad STD
B278MKTPSTD50Tibial Plateau Plate STD 5mm
B278MKTPSTD200Tibial Plateau Plate STD 20mm
B278MKTPSTD150Tibial Plateau Plate STD 15mm
B278MKTPSTD100Tibial Plateau Plate STD 10mm
B278MKTPSM50Tibial Plateau Plate SM 5mm
B278MKTPSM200Tibial Plateau Plate SM 20mm
B278MKTPSM150Tibial Plateau Plate SM 15mm
B278MKTPSM100Tibial Plateau Plate SM 10mm
B278JTSDFRSTD0JTS Distal Femur Right STD
B278JTSDFLXSM0JTS Distal Femur Left XSM
B278IMTRRHPSTD0Rotating Hinge Polyethylene Reamer: Standard
B278IMTRRHPSM0Rotating Hinge Polyethylene Reamer: Small
B278IMTRRHPEXSM0Rotating Hinge Polyethylene Reamer: Extra-Small
B278IMTRRHMSTD0Rotating Hinge Metal-Cased Reamer: Standard
B278IMTRRHMSM0Rotating Hinge Metal-Cased Reamer: Small
B278IMTRRHMEXSM0Rotating Hinge Metal-Cased Reamer: Extra-Small
B278IMTRFH0Fixed hinge Reamer
B278IMTPRMFHSTD0STD Positioning Plate: Holes
B278IMTPRMFHSM0SM Positioning Plate: Holes
B278IMTPRMFHEXSM0EXSM Positioning Plate: Holes
B278IMTPRHPSTD0STD Positioning Plate: Slots
B278IMTPRHPSM0SM Positioning Plate: Slots
B278IMTPRHPEXSM0EXSM Positioning Plate: Slots
B278IMTIBJIGRST0Tibial Cutting Guide: Rest
B278IMTIBJIGROD0Tibial Cutting Guide: Rod
B278IMTIBJIGPRG0Tibial Cutting Guide: Prongs
B278IMPBIMPSTD0Plastic Tibial Bearing Impactor: Standard
B278IMOSTME150Osteotome
B278IMHAM0Hammer
B278IMGENIMP0General Impactor
B278IMCIRPR0Circlip Pliers
B278IMBCSTD0Bush Compressor: Standard

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