| Primary Device ID | 00810094701345 |
| NIH Device Record Key | 30d39ba5-d50b-46c9-92b1-86f3f70c3cb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Tibial Baseplate, Revision |
| Version Model Number | 6201.05.000 |
| Company DUNS | 078416717 |
| Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@tjoinc.com | |
| Phone | 801-486-6070 |
| kcardall@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 |
| 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 | 00810094701345 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
[00810094701345]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-22 |
| Device Publish Date | 2025-05-14 |
| 00810094701307 | Tibial Baseplate Assembly, Revision, Sz 1 This contains the following implant numbers: 6200.01.0 |
| 00810094701246 | Tibial Baseplate, Revision, Sz 1 |
| 00810094701352 | Tibial Baseplate Assembly, Revision, Sz 6 This contains the following implant numbers: 6200.06.0 |
| 00810094701345 | Tibial Baseplate Assembly, Revision, Sz 5 This contains the following implant numbers: 6200.05.0 |
| 00810094701338 | Tibial Baseplate Assembly, Revision, Sz 4 This contains the following implant numbers: 6200.04.0 |
| 00810094701314 | Tibial Baseplate Assembly, Revision, Sz 3 This contains the following implant numbers: 6200.03.0 |
| 00810094701291 | Tibial Baseplate, Revision, Sz 6 |
| 00810094701284 | Tibial Baseplate, Revision, Sz 5 |
| 00810094701277 | Tibial Baseplate, Revision, Sz 4 |
| 00810094701260 | Tibial Baseplate, Revision, Sz 3 |
| 00810094701253 | Tibial Baseplate, Revision, Sz 2 |