| Primary Device ID | 00810094700201 |
| NIH Device Record Key | 4dd46e22-d5e8-4124-8a2c-58df72de325d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Femoral Augment, Posterior |
| Version Model Number | 6401.04.010 |
| 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 | 00810094700201 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
Radiation Sterilization
[00810094700201]
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 |
| 00810094700850 | Femoral Augment, Posterior, Size 7, 10mm |
| 00810094700843 | Femoral Augment, Posterior, Size 7, 5mm |
| 00810094700836 | Femoral Augment, Posterior, Size 6, 10mm |
| 00810094700829 | Femoral Augment, Posterior, Size 6, 5mm |
| 00810094700812 | Femoral Augment, Posterior, Size 5, 10mm |
| 00810094700805 | Femoral Augment, Posterior, Size 5, 5mm |
| 00810094700799 | Femoral Augment, Posterior, Size 4, 10mm |
| 00810094700782 | Femoral Augment, Posterior, Size 4, 5mm |
| 00810094700775 | Femoral Augment, Posterior, Size 3, 10mm |
| 00810094700768 | Femoral Augment, Posterior, Size 3, 5mm |
| 00810094700751 | Femoral Augment, Posterior, Size 2, 10mm |
| 00810094700744 | Femoral Augment, Posterior, Size 2, 5mm |
| 00810094700737 | Femoral Augment, Posterior, Size 1, 10mm |
| 00810094700720 | Femoral Augment, Posterior, Size 1, 5mm |
| 00810094700263 | Femoral Augment & Screw, Posterior, Size 7, 10mm |
| 00810094700256 | Femoral Augment & Screw, Posterior, Size 7, 5mm |
| 00810094700249 | Femoral Augment & Screw, Posterior, Size 6-7, 10mm |
| 00810094700232 | Femoral Augment & Screw, Posterior, Size 6-7, 5mm |
| 00810094700225 | Femoral Augment & Screw, Posterior, Size 5-7, 10mm |
| 00810094700218 | Femoral Augment & Screw, Posterior, Size 5-7, 5mm |
| 00810094700201 | Femoral Augment & Screw, Posterior, Size 4-5, 10mm |
| 00810094700195 | Femoral Augment & Screw, Posterior, Size 4-5, 5mm |
| 00810094700188 | Femoral Augment & Screw, Posterior, Size 3-4, 10mm |
| 00810094700171 | Femoral Augment & Screw, Posterior, Size 3-4, 5mm |
| 00810094700164 | Femoral Augment & Screw, Posterior, Size 2-3, 10mm |
| 00810094700157 | Femoral Augment & Screw, Posterior, Size 2-3, 5mm |
| 00810094700140 | Femoral Augment & Screw, Posterior, Size 1-2, 10mm |
| 00810094700133 | Femoral Augment & Screw, Posterior, Size 1-2, 5mm |