| Primary Device ID | 00814703011894 |
| NIH Device Record Key | 19e94ba5-856c-4389-bedc-9c1d114ad410 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Knee Sombrero Patella, Size 4, 10mm |
| Version Model Number | 5501.04.010 |
| 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 | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(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 |
| 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 | 00814703011894 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
[00814703011894]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-22 |
| 00810094691851 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 1 |
| 00810094691868 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 2 and 3 |
| 00810094691875 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 4 and 5 |
| 00810094691882 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 6 and 7 |
| 00819251021197 - Femoral Stem Impactor with Anteversion | 2023-12-19 Femoral Stem Impactor with Anteversion |
| 00819251020503 - Acetabular Cup Sizer | 2023-12-05 Acetabular Cup Sizer, 48mm |
| 00819251020510 - Acetabular Cup Sizer | 2023-12-05 Acetabular Cup Sizer, 50mm |
| 00819251020527 - Acetabular Cup Sizer | 2023-12-05 Acetabular Cup Sizer, 52mm |