| Primary Device ID | 00819251026567 |
| NIH Device Record Key | 0fee388a-c65d-46f0-be48-4dbf76eb37fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tibial Insert Trial, PS-Post, Klassic ONE |
| Version Model Number | 2254.01.011 |
| 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 | |
| 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 | |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 00819251026567 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
[00819251026567]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2020-10-09 |
| 00819251026901 | Tibial Insert Trial,PS-Post, size 6, 16mm |
| 00819251026895 | Tibial Insert Trial,PS-Post, size 6, 14mm |
| 00819251026888 | Tibial Insert Trial,PS-Post, size 6, 13mm |
| 00819251026871 | Tibial Insert Trial,PS-Post, size 6, 12mm |
| 00819251026864 | Tibial Insert Trial,PS-Post, size 6, 11mm |
| 00819251026857 | Tibial Insert Trial,PS-Post, size 6, 10mm |
| 00819251026840 | Tibial Insert Trial,PS-Post, size 5, 16mm |
| 00819251026833 | Tibial Insert Trial,PS-Post, size 5, 14mm |
| 00819251026826 | Tibial Insert Trial,PS-Post, size 5, 13mm |
| 00819251026819 | Tibial Insert Trial,PS-Post, size 5, 12mm |
| 00819251026802 | Tibial Insert Trial,PS-Post, size 5, 11mm |
| 00819251026796 | Tibial Insert Trial,PS-Post, size 5, 10mm |
| 00819251026789 | Tibial Insert Trial,PS-Post, size 4, 16mm |
| 00819251026772 | Tibial Insert Trial,PS-Post, size 4, 14mm |
| 00819251026765 | Tibial Insert Trial,PS-Post, size 4, 13mm |
| 00819251026758 | Tibial Insert Trial,PS-Post, size 4, 12mm |
| 00819251026741 | Tibial Insert Trial,PS-Post, size 4, 11mm |
| 00819251026734 | Tibial Insert Trial,PS-Post, size 4, 10mm |
| 00819251026727 | Tibial Insert Trial,PS-Post, size 3, 16mm |
| 00819251026710 | Tibial Insert Trial,PS-Post, size 3, 14mm |
| 00819251026703 | Tibial Insert Trial,PS-Post, size 3, 13mm |
| 00819251026697 | Tibial Insert Trial,PS-Post, size 3, 12mm |
| 00819251026680 | Tibial Insert Trial,PS-Post, size 3, 11mm |
| 00819251026673 | Tibial Insert Trial,PS-Post, size 3, 10mm |
| 00819251026666 | Tibial Insert Trial,PS-Post, size 2, 16mm |
| 00819251026659 | Tibial Insert Trial,PS-Post, size 2, 14mm |
| 00819251026642 | Tibial Insert Trial,PS-Post, size 2, 13mm |
| 00819251026635 | Tibial Insert Trial,PS-Post, size 2, 12mm |
| 00819251026628 | Tibial Insert Trial,PS-Post, size 2, 11mm |
| 00819251026611 | Tibial Insert Trial,PS-Post, size 2, 10mm |
| 00819251026604 | Tibial Insert Trial,PS-Post, size 1, 16mm |
| 00819251026598 | Tibial Insert Trial,PS-Post, size 1, 14mm |
| 00819251026581 | Tibial Insert Trial,PS-Post, size 1, 13mm |
| 00819251026574 | Tibial Insert Trial,PS-Post, size 1, 12mm |
| 00819251026567 | Tibial Insert Trial,PS-Post, size 1, 11mm |
| 00819251026550 | Tibial Insert Trial,PS-Post, size 1, 10mm |
| 00819251029575 | Tibial Insert Trial,PS-Post, size 6, 24mm |
| 00819251029568 | Tibial Insert Trial,PS-Post, size 6, 21mm |
| 00819251029551 | Tibial Insert Trial,PS-Post, size 6, 18mm |
| 00819251029544 | Tibial Insert Trial,PS-Post, size 5, 24mm |
| 00819251029537 | Tibial Insert Trial,PS-Post, size 5, 21mm |
| 00819251029520 | Tibial Insert Trial,PS-Post, size 5, 18mm |
| 00819251029513 | Tibial Insert Trial,PS-Post, size 4, 24mm |
| 00819251029506 | Tibial Insert Trial,PS-Post, size 4, 21mm |
| 00819251029490 | Tibial Insert Trial,PS-Post, size 4, 18mm |
| 00819251029483 | Tibial Insert Trial,PS-Post, size 3, 24mm |
| 00819251029476 | Tibial Insert Trial,PS-Post, size 3, 21mm |
| 00819251029469 | Tibial Insert Trial,PS-Post, size 3, 18mm |
| 00819251029452 | Tibial Insert Trial,PS-Post, size 2, 24mm |
| 00819251029445 | Tibial Insert Trial,PS-Post, size 2, 21mm |