| Primary Device ID | 08800017264004 |
| NIH Device Record Key | 90ac950f-efb4-433c-8bb0-2f821d6fb12d |
| Commercial Distribution Discontinuation | 2020-01-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EXULT Knee Replacement System |
| Version Model Number | K3.IBX.4775-18T |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800017264004 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2020-01-10 |
| 08800017294872 | Tibial Insert Trial CR #08 T18 |
| 08800017294865 | Tibial Insert Trial CR #08 T16 |
| 08800017294858 | Tibial Insert Trial CR #08 T14 |
| 08800017294841 | Tibial Insert Trial CR #08 T13 |
| 08800017294834 | Tibial Insert Trial CR #08 T12 |
| 08800017294827 | Tibial Insert Trial CR #08 T11 |
| 08800017294810 | Tibial Insert Trial CR #08 T10 |
| 08800017294803 | Tibial Insert Trial CR #08 T09 |
| 08800017294797 | Tibial Insert Trial CR #07 T24 |
| 08800017294780 | Tibial Insert Trial CR #07 T22 |
| 08800017294773 | Tibial Insert Trial CR #07 T20 |
| 08800017294766 | Tibial Insert Trial CR #07 T18 |
| 08800017294759 | Tibial Insert Trial CR #07 T16 |
| 08800017294742 | Tibial Insert Trial CR #07 T14 |
| 08800017294735 | Tibial Insert Trial CR #07 T13 |
| 08800017294728 | Tibial Insert Trial CR #07 T12 |
| 08800017294711 | Tibial Insert Trial CR #07 T11 |
| 08800017294704 | Tibial Insert Trial CR #07 T10 |
| 08800017294698 | Tibial Insert Trial CR #07 T09 |
| 08800017294681 | Tibial Insert Trial CR #06 T24 |
| 08800017294674 | Tibial Insert Trial CR #06 T22 |
| 08800017294667 | Tibial Insert Trial CR #06 T20 |
| 08800017294650 | Tibial Insert Trial CR #06 T18 |
| 08800017294643 | Tibial Insert Trial CR #06 T16 |
| 08800017294636 | Tibial Insert Trial CR #06 T14 |
| 08800017294629 | Tibial Insert Trial CR #06 T13 |
| 08800017294612 | Tibial Insert Trial CR #06 T12 |
| 08800017294605 | Tibial Insert Trial CR #06 T11 |
| 08800017294599 | Tibial Insert Trial CR #06 T10 |
| 08800017294582 | Tibial Insert Trial CR #06 T09 |
| 08800017294575 | Tibial Insert Trial CR #05 T24 |
| 08800017294568 | Tibial Insert Trial CR #05 T22 |
| 08800017294551 | Tibial Insert Trial CR #05 T20 |
| 08800017294544 | Tibial Insert Trial CR #05 T18 |
| 08800017294537 | Tibial Insert Trial CR #05 T16 |
| 08800017294520 | Tibial Insert Trial CR #05 T14 |
| 08800017294513 | Tibial Insert Trial CR #05 T13 |
| 08800017294506 | Tibial Insert Trial CR #05 T12 |
| 08800017294490 | Tibial Insert Trial CR #05 T11 |
| 08800017294483 | Tibial Insert Trial CR #05 T10 |
| 08800017294476 | Tibial Insert Trial CR #05 T09 |
| 08800017294469 | Tibial Insert Trial CR #04 T24 |
| 08800017294452 | Tibial Insert Trial CR #04 T22 |
| 08800017294445 | Tibial Insert Trial CR #04 T20 |
| 08800017294438 | Tibial Insert Trial CR #04 T18 |
| 08800017294421 | Tibial Insert Trial CR #04 T16 |
| 08800017294414 | Tibial Insert Trial CR #04 T14 |
| 08800017294407 | Tibial Insert Trial CR #04 T13 |
| 08800017294391 | Tibial Insert Trial CR #04 T12 |
| 08800017294384 | Tibial Insert Trial CR #04 T11 |