| Primary Device ID | 00814703011559 |
| NIH Device Record Key | 2e52c83b-e272-4c34-91b6-3bd9a3939384 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 32mm BIOLOX delta Femoral Head, 12/14 taper, +7mm Head Length |
| Version Model Number | 3203.32.700 |
| 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 | +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 |
| 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 |
| Device Size Text, specify | 0 |
| 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 | 00814703011559 [Primary] |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
[00814703011559]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-21 |
| 00810094692278 - Universal Cone Impactor Head | 2025-05-02 Cone Impactor Head, Size 1-2, 12° |
| 00810094692285 - Universal Cone Impactor Head | 2025-05-02 Cone Impactor Head, Size 3-4, 18° |
| 00810094692292 - Universal Cone Impactor Head | 2025-05-02 Cone Impactor Head, Size 5-7, 24° |
| 00810094692308 - Cone Reamer Guide | 2025-05-02 Cone Reamer Guide, 100mm |
| 00810094692315 - Cone Reamer Guide | 2025-05-02 Cone Reamer Guide, 75mm |
| 00810094692452 - Klassic ONE Universal Cone & Revision Baseplate Instrumentation Tray | 2025-05-02 Cone & Revision Baseplate Instrumentation Tray |
| 00810094692469 - Klassic ONE Universal Cone & Revision Baseplate Tray, Pin Mat Insert | 2025-05-02 Cone & Revision Baseplate Instrumentation Tray, Pin Mat Insert |
| 00810094692131 - Distal Hip Reamer, Sz 6 | 2025-01-30 Distal Hip Reamer, Sz 6 |