| Primary Device ID | 00810094692322 |
| NIH Device Record Key | 27031659-421f-466f-8267-82b39a2ee778 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spline Wrench, Closed |
| Version Model Number | 2017.00.100 |
| 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 |
| 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 | 00810094692322 [Primary] |
| HXC | Wrench |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
Moist Heat or Steam Sterilization
[00810094692322]
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 |
| 00810094692476 - Narrow Distal Femur Cut Block | 2025-09-04 Narrow Distal Femur Cut Block |
| 00810094692544 - Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert | 2025-08-05 Cone & Revision Baseplate Instrumentation Tray, Baseplate Insert |
| 00810094692339 - Acetabular Reamer Adapter | 2025-07-04 |
| 00810094691790 - Klassic Knee Templates, Stem Extensions | 2025-05-22 Knee Templates, Stem Extensions |
| 00810094692322 - Spline Wrench, Closed | 2025-05-22 |
| 00810094692322 - Spline Wrench, Closed | 2025-05-22 |
| 00810094692346 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 10 |
| 00810094692353 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 11 |
| 00810094692360 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 12 |