| Primary Device ID | B707128310070210 |
| NIH Device Record Key | dde04576-9d3a-4964-83f4-4f42409e876b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALX LLIF 12-15MM x 7 DEG x 40MM |
| Version Model Number | 12831007021 |
| 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 | B707128310070210 [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 | 2019-07-25 |
| B707125355740300 - DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA) | 2026-03-13 INCLUDES: CANNULA 30MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740400 - DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA) | 2026-03-13 INCLUDES: CANNULA 40MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740500 - DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA) | 2026-03-13 INCLUDES: CANNULA 50MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740600 - DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA) | 2026-03-13 INCLUDES: CANNULA 60MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740700 - DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA) | 2026-03-13 INCLUDES: CANNULA 70MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740800 - DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA) | 2026-03-13 INCLUDES: CANNULA 80MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355740900 - DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA) | 2026-03-13 INCLUDES: CANNULA 90MM HEMOSTATIC AGENT DELIVERY TUBE |
| B707125355741000 - DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA) | 2026-03-13 INCLUDES: CANNULA 100MM HEMOSTATIC AGENT DELIVERY TUBE |