| Primary Device ID | 00819251020497 |
| NIH Device Record Key | 0278ef19-cb72-47a6-a5a9-0aba3a643601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anterior Starter Broach |
| Version Model Number | 1115.00.000 |
| 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 | true |
| 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 | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819251020497 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
[00819251020497]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| 00819251020480 - Modular Broach Holder, Single Offset | 2024-05-08 Modular Broach Holder, Single Offset |
| 00819251020497 - Anterior Starter Broach | 2024-05-08Anterior Starter Broach |
| 00819251020497 - Anterior Starter Broach | 2024-05-08 Anterior Starter Broach |
| 00810094691851 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 1 |
| 00810094691868 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 2 and 3 |
| 00810094691875 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 4 and 5 |
| 00810094691882 - PS-Post Box Resection Guide | 2024-02-22 PS-Post Box Resection Guide, Size 6 and 7 |
| 00819251021197 - Femoral Stem Impactor with Anteversion | 2023-12-19 Femoral Stem Impactor with Anteversion |
| 00819251020503 - Acetabular Cup Sizer | 2023-12-05 Acetabular Cup Sizer, 48mm |