| Primary Device ID | 00814703016660 |
| NIH Device Record Key | f252bfe3-2557-49d6-908f-ef9722614d3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Femur, Nonporous |
| Version Model Number | 5105.04.000 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814703016660 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703016660]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2019-02-28 |
| 00814703016691 | Femur, Nonporous, size 7 |
| 00814703016684 | Femur, Nonporous, size 6 |
| 00814703016677 | Femur, Nonporous, size 5 |
| 00814703016660 | Femur, Nonporous, size 4 |
| 00814703016653 | Femur, Nonporous, size 3 |
| 00814703016646 | Femur, Nonporous, size 2 |
| 00814703016639 | Femur, Nonporous, size 1 |