| Primary Device ID | 00814703011863 |
| NIH Device Record Key | d1329b4c-3a6c-4f33-8018-8b2dd862bfad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Knee Sombrero Patella, Size 1, 10mm |
| Version Model Number | 5501.01.010 |
| 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 | 00814703011863 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
Ethylene Oxide
[00814703011863]
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 |
| 00810094701246 - Klassic Tibial Baseplate, Revision | 2025-05-15 Tibial Baseplate, Revision, Sz 1 |
| 00810094701307 - Klassic Tibial Baseplate, Revision | 2025-05-15 Tibial Baseplate Assembly, Revision, Sz 1 This contains the following implant numbers: 6200.01.000 Klassic Tibial Baseplate, Rev |
| 00810094692278 - Universal Cone Impactor Head | 2025-05-02 Cone Impactor Head, Size 1-2, 12° |
| 00810094692285 - Universal Cone Impactor Head | 2025-05-02 Cone Impactor Head, Size 3-4, 18° |
| 00810094692292 - Universal Cone Impactor Head | 2025-05-02 Cone Impactor Head, Size 5-7, 24° |
| 00810094692308 - Cone Reamer Guide | 2025-05-02 Cone Reamer Guide, 100mm |
| 00810094692315 - Cone Reamer Guide | 2025-05-02 Cone Reamer Guide, 75mm |
| 00810094692452 - Klassic ONE Universal Cone & Revision Baseplate Instrumentation Tray | 2025-05-02 Cone & Revision Baseplate Instrumentation Tray |