| Primary Device ID | B707128310000060 |
| NIH Device Record Key | 0c43c843-db9f-44ce-9cef-963e899e7866 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALX LLIF 10-13MM x 12 DEG x 40MM |
| Version Model Number | 12831000006 |
| 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 | B707128310000060 [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 |
| B707125341260 - dualX Graft Delivery Tip (USA) | 2025-05-21 DUALX Graft Delivery Tip |
| B70712534146040 - DualX LLIF IMPLANT HOLDER 40mm | 2025-05-21 DUALX LLIF IMPLANT HOLDER 40mm |
| B707125341460450 - DualX LLIF IMPLANT HOLDER 45mm | 2025-05-21 DUALX LLIF IMPLANT HOLDER 45mm |
| B707125341460550 - DualX LLIF IMPLANT HOLDER 55mm | 2025-05-21 DUALX LLIF IMPLANT HOLDER 55mm |
| B707128400060010 - DUALXS T/PLIF LOCKOUT SCREW SHORT | 2025-05-21 DUALXS T/PLIF LOCKOUT SCREW SHORT |
| B707128450070 - DUALX LLIF IMPLANT STERILIZATION CADDY | 2025-05-21 LLIF IMPLANT STERILIZATION CADDY |
| B707129410010010 - DUALXS T/PLIF 12 DEG x 7-10MM | 2025-05-21 Lordosis & Heights: 12° x 7-10mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm) |
| B707128300090010 - DUALX LLIF LOCKOUT SCREW 2 X 40MM | 2025-05-08 DUALX LLIF LOCKOUT SCREW 2 X 40MM |