| Primary Device ID | 00814703017070 |
| NIH Device Record Key | 146b9246-a3ff-42b9-a2a0-b25a66c33c5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Femur with Aurum |
| Version Model Number | 5104.04.000 |
| 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 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com | |
| Phone | 8014866070 |
| bsiddoway@tjoinc.com |
| 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 | 00814703017070 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
[00814703017070]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-28 |
| Device Publish Date | 2022-01-20 |
| 00814703017100 | Femur with Aurum, size 7 |
| 00814703017094 | Femur with Aurum, size 6 |
| 00814703017087 | Femur with Aurum, size 5 |
| 00814703017070 | Femur with Aurum, size 4 |
| 00814703017063 | Femur with Aurum, size 3 |
| 00814703017056 | Femur with Aurum, size 2 |
| 00814703017049 | Femur with Aurum, size 1 |