| Primary Device ID | 00814703014956 |
| NIH Device Record Key | f94b111b-751a-4bf0-94e3-08f2773bc93d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 28mm BIOLOX OPTION Ceramic Revision Femoral Head, 16/18 taper |
| Version Model Number | 3204.28.000 |
| 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 | +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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814703014956 [Primary] |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
[00814703014956]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-13 |
| Device Publish Date | 2018-06-12 |
| 00810094701000 - Klassic Tibial Augment | 2024-12-16 Tibial Augment, Size 1-2, 5mm |
| 00810094701017 - Klassic Tibial Augment | 2024-12-16 Tibial Augment, Size 1-2, 10mm |
| 00810094701024 - Klassic Tibial Augment | 2024-12-16 Tibial Augment, Size 3-4, 5mm |
| 00810094701031 - Klassic Tibial Augment | 2024-12-16 Tibial Augment, Size 3-4, 10mm |
| 00810094701048 - Klassic Tibial Augment | 2024-12-16 Tibial Augment, Size 5-6, 5mm |
| 00810094701055 - Klassic Tibial Augment | 2024-12-16 Tibial Augment, Size 5-6, 10mm |
| 00810094701062 - Klassic Tibial Augment & Screw | 2024-12-16 Includes: Tibial Augment, Size 1-2, 5mm (00810094701000) and Augment Screw, 5mm (00814703019968) |
| 00810094701079 - Klassic Tibial Augment & Screw | 2024-12-16 Includes: Tibial Augment, Size 1-2, 10mm (00810094701017) and Augment Screw, 10mm (00814703019975) |