| Primary Device ID | B707128220010190 |
| NIH Device Record Key | 2a3ac9c1-131c-4588-b148-50100deb6bb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT DUALX PLIF 15 DEG x 11-14MM |
| Version Model Number | 12822001019 |
| 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 | B707128220010190 [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 | 2025-05-05 |
| Device Publish Date | 2025-04-25 |
| B707125355860 - DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA) | 2025-06-06 HEMOSTATIC AGENT DELIVERY TUBE US MANUFACTURE |
| 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 |