| Primary Device ID | 08800065800100 |
| NIH Device Record Key | 8ca37f37-4c26-4c26-a7b5-70b9b09d91c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3d Lumbar Cage |
| Version Model Number | PT1009264 |
| Company DUNS | 689845119 |
| Company Name | FIMS.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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800065800100 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 08800065800711 | PT1511268 |
| 08800065800704 | PT1411268 |
| 08800065800698 | PT1311268 |
| 08800065800681 | PT1211268 |
| 08800065800674 | PT1111268 |
| 08800065800667 | PT1011268 |
| 08800065800650 | PT0911268 |
| 08800065800643 | PT0811268 |
| 08800065800636 | PT1511264 |
| 08800065800629 | PT1411264 |
| 08800065800612 | PT1311264 |
| 08800065800605 | PT1211264 |
| 08800065800599 | PT1111264 |
| 08800065800582 | PT1011264 |
| 08800065800575 | PT0911264 |
| 08800065800568 | PT0811264 |
| 08800065808335 | TT1112324 |
| 08800065808328 | TT1012324 |
| 08800065808311 | TT0912324 |
| 08800065808304 | TT0812324 |
| 08800065834693 | PT0709264 |
| 08800065800087 | PT0809264 |
| 08800065800230 | PT1509268 |
| 08800065800223 | PT1409268 |
| 08800065800216 | PT1309268 |
| 08800065800209 | PT1209268 |
| 08800065800193 | PT1109268 |
| 08800065800186 | PT1009268 |
| 08800065800179 | PT0909268 |
| 08800065800162 | PT0809268 |
| 08800065800155 | PT1509264 |
| 08800065800148 | PT1409264 |
| 08800065800131 | PT1309264 |
| 08800065800124 | PT1209264 |
| 08800065800117 | PT1109264 |
| 08800065800100 | PT1009264 |
| 08800065800094 | PT0909264 |