Primary Device ID | 00810094701024 |
NIH Device Record Key | dea0f2c8-5ceb-47ab-9b44-2d6da8109d3b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klassic Tibial Augment |
Version Model Number | 6404.03.005 |
Company DUNS | 078416717 |
Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810094701024 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
[00810094701024]
Radiation Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-16 |
Device Publish Date | 2024-12-06 |
00810094701055 | Tibial Augment, Size 5-6, 10mm |
00810094701048 | Tibial Augment, Size 5-6, 5mm |
00810094701031 | Tibial Augment, Size 3-4, 10mm |
00810094701024 | Tibial Augment, Size 3-4, 5mm |
00810094701017 | Tibial Augment, Size 1-2, 10mm |
00810094701000 | Tibial Augment, Size 1-2, 5mm |