| Primary Device ID | 00818345021327 |
| NIH Device Record Key | e3939d4f-dc8f-401e-ac6a-356084568d15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoFuse Ti3D PLIF/TLIF |
| Version Model Number | C3010-16 |
| Company DUNS | 080386764 |
| Company Name | HT MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 00818345021327 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2017-11-07 |
| 00818345021945 | Ti3D CAGE 32L x 12W x 18H |
| 00818345021938 | Ti3D CAGE 32L x 12W x 17H |
| 00818345021921 | Ti3D CAGE 32L x 12W x 16H |
| 00818345021914 | Ti3D CAGE 32L x 12W x 15H |
| 00818345021907 | Ti3D CAGE 32L x 12W x 14H |
| 00818345021891 | Ti3D CAGE 32L x 12W x 13H |
| 00818345021884 | Ti3D CAGE 32L x 12W x 12H |
| 00818345021877 | Ti3D CAGE 32L x 12W x 11H |
| 00818345021860 | Ti3D CAGE 32L x 12W x 10H |
| 00818345021853 | Ti3D CAGE 32L x 12W x 9H |
| 00818345021846 | Ti3D CAGE 32L x 12W x 8H |
| 00818345021839 | Ti3D CAGE 32L x 12W x 7H |
| 00818345021822 | Ti3D CAGE 30L x 12W x 18H |
| 00818345021815 | Ti3D CAGE 30L x 12W x 17H |
| 00818345021808 | Ti3D CAGE 30L x 12W x 16H |
| 00818345021792 | Ti3D CAGE 30L x 12W x 15H |
| 00818345021785 | Ti3D CAGE 30L x 12W x 14H |
| 00818345021778 | Ti3D CAGE 30L x 12W x 13H |
| 00818345021761 | Ti3D CAGE 30L x 12W x 12H |
| 00818345021754 | Ti3D CAGE 30L x 12W x 11H |
| 00818345021747 | Ti3D CAGE 30L x 12W x 10H |
| 00818345021730 | Ti3D CAGE 30L x 12W x 9H |
| 00818345021723 | Ti3D CAGE 30L x 12W x 8H |
| 00818345021716 | Ti3D CAGE 30L x 12W x 7H |
| 00818345021709 | Ti3D CAGE 24L x 12W x 18H |
| 00818345021693 | Ti3D CAGE 24L x 12W x 17H |
| 00818345021686 | Ti3D CAGE 24L x 12W x 16H |
| 00818345021679 | Ti3D CAGE 24L x 12W x 15H |
| 00818345021662 | Ti3D CAGE 24L x 12W x 14H |
| 00818345021655 | Ti3D CAGE 24L x 12W x 13H |
| 00818345021648 | Ti3D CAGE 24L x 12W x 12H |
| 00818345021631 | Ti3D CAGE 24L x 12W x 11H |
| 00818345021624 | Ti3D CAGE 24L x 12W x 10H |
| 00818345021617 | Ti3D CAGE 24L x 12W x 9H |
| 00818345021600 | Ti3D CAGE 24L x 12W x 8H |
| 00818345021594 | Ti3D CAGE 24L x 12W x 7H |
| 00818345021587 | Ti3D CAGE 20L x 12W x 18H |
| 00818345021570 | Ti3D CAGE 20L x 12W x 17H |
| 00818345021563 | Ti3D CAGE 20L x 12W x 16H |
| 00818345021556 | Ti3D CAGE 20L x 12W x 15H |
| 00818345021549 | Ti3D CAGE 20L x 12W x 14H |
| 00818345021532 | Ti3D CAGE 20L x 12W x 13H |
| 00818345021525 | Ti3D CAGE 20L x 12W x 12H |
| 00818345021518 | Ti3D CAGE 20L x 12W x 11H |
| 00818345021501 | Ti3D CAGE 20L x 12W x 10H |
| 00818345021495 | Ti3D CAGE 20L x 12W x 9H |
| 00818345021488 | Ti3D CAGE 20L x 12W x 8H |
| 00818345021471 | Ti3D CAGE 20L x 12W x 7H |
| 00818345021464 | Ti3D CAGE 32L x 10W x 18H |
| 00818345021457 | Ti3D CAGE 32L x 10W x 17H |