| Primary Device ID | B707128320070120 |
| NIH Device Record Key | ef8aa814-cf34-4a45-896a-c1f20741ece8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT DUALX LLIF 10-13MM x 7 DEG x 45MM |
| Version Model Number | 12832007012 |
| 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 | B707128320070120 [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 |
| B70712833007012A0 | LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 45mm Lateral Width: 46.8 |
| B707128330070120 | LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 45mm Collapsed Width (mm) |
| B707128320070120 | LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 45mm Collapsed Width (mm) |