| Primary Device ID | 00810094700331 |
| NIH Device Record Key | 226b4fc4-2a67-46c0-aa9d-4a6b8eaceff4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Femoral Augment, Distal |
| Version Model Number | 6403.04.005 |
| 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 | |
| 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 |
| 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 |
| 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 | 00810094700331 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
[00810094700331]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-11 |
| Device Publish Date | 2024-06-03 |
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| 00810094700973 | Femoral Augment, Distal, Size 6, 10mm |
| 00810094700966 | Femoral Augment, Distal, Size 6, 5mm |
| 00810094700959 | Femoral Augment, Distal, Size 5, 10mm |
| 00810094700942 | Femoral Augment, Distal, Size 5, 5mm |
| 00810094700935 | Femoral Augment, Distal, Size 4, 10mm |
| 00810094700928 | Femoral Augment, Distal, Size 4, 5mm |
| 00810094700911 | Femoral Augment, Distal, Size 3, 10mm |
| 00810094700904 | Femoral Augment, Distal, Size 3, 5mm |
| 00810094700898 | Femoral Augment, Distal, Size 2, 10mm |
| 00810094700881 | Femoral Augment, Distal, Size 2, 5mm |
| 00810094700874 | Femoral Augment, Distal, Size 1, 10mm |
| 00810094700867 | Femoral Augment, Distal, Size 1, 5mm |
| 00810094700409 | Femoral Augment, Distal, Size 7, 10mm |
| 00810094700393 | Femoral Augment, Distal, Size 7, 5mm |
| 00810094700386 | Femoral Augment, Distal, Size 6-7, 10mm |
| 00810094700379 | Femoral Augment, Distal, Size 6-7, 5mm |
| 00810094700362 | Femoral Augment, Distal, Size 5-7, 10mm |
| 00810094700355 | Femoral Augment, Distal, Size 5-7, 5mm |
| 00810094700348 | Femoral Augment, Distal, Size 4-5, 10mm |
| 00810094700331 | Femoral Augment, Distal, Size 4-5, 5mm |
| 00810094700324 | Femoral Augment, Distal, Size 3-4, 10mm |
| 00810094700317 | Femoral Augment, Distal, Size 3-4, 5mm |
| 00810094700300 | Femoral Augment, Distal, Size 2-3, 10mm |
| 00810094700294 | Femoral Augment, Distal, Size 2-3, 5mm |
| 00810094700287 | Femoral Augment, Distal, Size 1-2, 10mm |
| 00810094700270 | Femoral Augment, Distal, Size 1-2, 5mm |