| Primary Device ID | 08800068950161 |
| NIH Device Record Key | 5b2ffd05-1184-49a6-9809-098adb981e2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOSPA TKR SYSTEM |
| Version Model Number | KA.SCR.0310 |
| Company DUNS | 688739895 |
| Company Name | Corentec Co., Ltd |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800068950161 [Primary] |
| HWT | Template |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
[08800068950161]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-30 |
| Device Publish Date | 2021-12-22 |
| 08800068950215 | LOSPA Tibial Insert Trial CR #03 T08 |
| 08800068950161 | Tibial Insert Trial CR #03 T10 |
| 08800068950772 | Tibial Insert Trial CR #06 T24 |
| 08800068950765 | Tibial Insert Trial CR #06 T22 |
| 08800068950758 | Tibial Insert Trial CR #06 T20 |
| 08800068950741 | Tibial Insert Trial CR #06 T18 |
| 08800068950734 | Tibial Insert Trial CR #06 T16 |
| 08800068950727 | Tibial Insert Trial CR #06 T14 |
| 08800068950710 | Tibial Insert Trial CR #06 T12 |
| 08800068950703 | Tibial Insert Trial CR #06 T10 |
| 08800068950697 | Tibial Insert Trial CR #06 T08 |
| 08800068950680 | Tibial Insert Trial CR #05 T18 |
| 08800068950673 | Tibial Insert Trial CR #05 T16 |
| 08800068950666 | Tibial Insert Trial CR #05 T14 |
| 08800068950659 | Tibial Insert Trial CR #05 T08 |
| 08800068950642 | Tibial Insert Trial CR #05 T24 |
| 08800068950635 | Tibial Insert Trial CR #05 T22 |
| 08800068950628 | Tibial Insert Trial CR #05 T20 |
| 08800068950611 | Tibial Insert Trial CR #05 T12 |
| 08800068950604 | Tibial Insert Trial CR #05 T10 |
| 08800068950574 | Tibial Insert Trial CR #04 T18 |
| 08800068950567 | Tibial Insert Trial CR #04 T16 |
| 08800068950550 | Tibial Insert Trial CR #04 T14 |
| 08800068950543 | Tibial Insert Trial CR #04 T08 |
| 08800068950536 | Tibial Insert Trial CR #04 T24 |
| 08800068950529 | Tibial Insert Trial CR #04 T22 |
| 08800068950512 | Tibial Insert Trial CR #04 T20 |
| 08800068950505 | Tibial Insert Trial CR #04 T12 |
| 08800068950499 | Tibial Insert Trial CR #04 T10 |
| 08800068950246 | Tibial Insert Trial CR #03 T18 |
| 08800068950239 | Tibial Insert Trial CR #03 T16 |
| 08800068950222 | Tibial Insert Trial CR #03 T14 |
| 08800068950208 | Tibial Insert Trial CR #03 T24 |
| 08800068950192 | Tibial Insert Trial CR #03 T22 |
| 08800068950185 | Tibial Insert Trial CR #03 T20 |
| 08800068950178 | Tibial Insert Trial CR #03 T12 |
| 08800068960450 | Tibial Insert Trial CR #11 T22 |
| 08800068954909 | Tibial Insert Trial PS #05 T10 |
| 08800068953889 | Tibial Insert Trial PS #05 T18 |
| 08800068953872 | Tibial Insert Trial PS #05 T16 |
| 08800068953865 | Tibial Insert Trial PS #05 T14 |
| 08800068953858 | Tibial Insert Trial PS #05 T08 |
| 08800068953827 | Tibial Insert Trial PS #05 T20 |
| 08800068953810 | Tibial Insert Trial PS #05 T12 |
| 08800068953629 | Tibial Insert Trial PS #04 T18 |
| 08800068953612 | Tibial Insert Trial PS #03 T18 |
| 08800068953605 | Tibial Insert Trial PS #04 T16 |
| 08800068953599 | Tibial Insert Trial PS #03 T16 |
| 08800068953582 | Tibial Insert Trial PS #04 T14 |
| 08800068953575 | Tibial Insert Trial PS #03 T14 |