| Primary Device ID | 00810094700485 |
| NIH Device Record Key | cc252e61-932c-4f04-87a0-7b16b60760cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Cone |
| Version Model Number | 6800.02.012 |
| 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 | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| kcardall@tjoinc.com | |
| Phone | 8014866070 |
| 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 |
| 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 | 00810094700485 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
[00810094700485]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-12 |
| Device Publish Date | 2024-09-04 |
| 00810094700539 | Cone, Size 7, 24 degree |
| 00810094700522 | Cone, Size 6, 24 degree |
| 00810094700515 | Cone, Size 5, 24 degree |
| 00810094700508 | Cone, Size 4, 18 degree |
| 00810094700492 | Cone, Size 3, 18 degree |
| 00810094700485 | Cone, Size 2, 12 degree |
| 00810094700478 | Cone, Size 1, 12 degree |