| Primary Device ID | B707128320050030 |
| NIH Device Record Key | 3eed16b2-7d33-4886-a2e2-11f377cc2c5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT DUALX LLIF 7-9MM x 0 DEG x 50MM |
| Version Model Number | 12832005003 |
| 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 | B707128320050030 [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 |
| B70712833005003A0 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 50mm Lateral Width: 51.8mm |
| B707128330050030 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 50mm Collapsed Width (mm): |
| B707128320050030 | LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 50mm Collapsed Width (mm): |