| Primary Device ID | B707128320050040 |
| NIH Device Record Key | adef1c30-855a-48a5-a021-2a5ef183557e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT DUALX LLIF 7-9MM x 0 DEG x 55MM |
| Version Model Number | 12832005004 |
| 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 | B707128320050040 [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 |
| B70712833005004A0 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 55mm Lateral Width: 56.8mm |
| B707128330050040 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 55mm Collapsed Width (mm): |
| B707128320050040 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 55mm Collapsed Width (mm): |