| Primary Device ID | 00810094692421 |
| NIH Device Record Key | 66972600-44d2-485c-a65d-eb673039db77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intramedullary Reamer, Revision |
| Version Model Number | 2026.18.000 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@tjoinc.com | |
| Phone | 801-486-6070 |
| bsiddoway@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 | 00810094692421 [Primary] |
| HTO | Reamer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam Sterilization
[00810094692421]
Moist Heat or Steam 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 |
| 00810094692445 | Intramedullary Reamer, Revision, Sz 20 |
| 00810094692438 | Intramedullary Reamer, Revision, Sz 19 |
| 00810094692421 | Intramedullary Reamer, Revision, Sz 18 |
| 00810094692414 | Intramedullary Reamer, Revision, Sz 17 |
| 00810094692407 | Intramedullary Reamer, Revision, Sz 16 |
| 00810094692391 | Intramedullary Reamer, Revision, Sz 15 |
| 00810094692384 | Intramedullary Reamer, Revision, Sz 14 |
| 00810094692377 | Intramedullary Reamer, Revision, Sz 13 |
| 00810094692360 | Intramedullary Reamer, Revision, Sz 12 |
| 00810094692353 | Intramedullary Reamer, Revision, Sz 11 |
| 00810094692346 | Intramedullary Reamer, Revision, Sz 10 |