| Primary Device ID | B707125310060020 |
| NIH Device Record Key | 9c474ae4-e215-4a55-b7e7-12055308b831 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALX TLIF 0 DEG x 8-11MM |
| Version Model Number | 12531006002 |
| Company DUNS | 081021000 |
| Company Name | AMPLIFY SURGICAL, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B707125310060020 [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 | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-07-22 |
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| B70712535588001US0 - DUALX DUAL PORT CANNULA 30MM | 2025-06-06 30MM US MANUFACTURE |
| B70712535588002US0 - DUALX DUAL PORT CANNULA 40MM | 2025-06-06 40MM US MANUFACTURE |
| B70712535588003US0 - DUALX DUAL PORT CANNULA 50MM | 2025-06-06 50MM US MANUFACTURE |
| B70712535588004US0 - DUALX DUAL PORT CANNULA 60MM | 2025-06-06 60MM US MANUFACTURE |
| B70712535588005US0 - DUALX DUAL PORT CANNULA 70MM | 2025-06-06 70MM US MANUFACTURE |
| B70712535588006US0 - DUALX DUAL PORTAL CANNULA 80MM | 2025-06-06 80MM US MANUFACTURE |
| B70712535588007US0 - DUALX DUAL PORTAL CANNULA 90MM | 2025-06-06 90MM US MANUFACTURE |