| Primary Device ID | 00814703019999 |
| NIH Device Record Key | 0b119158-b774-48cc-a8d0-e5f2f5be12d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Femoral Augment Screw, Distal |
| Version Model Number | 6407.00.010 |
| 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 | 00814703019999 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
Radiation Sterilization
[00814703019999]
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 |
| 00814703019999 | Femoral Augment Screw, Distal, 10mm |
| 00814703019982 | Femoral Augment Screw, Distal, 5mm |