| Primary Device ID | 00814703016738 |
| NIH Device Record Key | a294b5d1-cea3-4dfc-8ad3-b631cf822718 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic Femur with Cobalt 3D |
| Version Model Number | 5106.04.000 |
| 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 | 00814703016738 [Primary] |
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703016738]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-28 |
| 00814703016769 | Femur with Cobalt 3D, size 7 |
| 00814703016752 | Femur with Cobalt 3D, size 6 |
| 00814703016745 | Femur with Cobalt 3D, size 5 |
| 00814703016738 | Femur with Cobalt 3D, size 4 |
| 00814703016721 | Femur with Cobalt 3D, size 3 |
| 00814703016714 | Femur with Cobalt 3D, size 2 |