| Primary Device ID | B707128220000040 |
| NIH Device Record Key | 84fb1eef-1d3d-463e-9f82-e1255df3bcaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT DUALX PLIF 8 DEG x 8-11MM |
| Version Model Number | 12822000004 |
| 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 | B707128220000040 [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 | 2022-03-09 |
| Device Publish Date | 2022-03-01 |
| B70712823000004A0 | PLIF Lordosis & Heights: 8° x 8-11mm Lateral Width: 21.1 mm Superior - Inferior Height: 11.5mm |
| B707128230000040 | PLIF Lordosis & Heights: 8° x 8-11mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Coll |
| B707128220000040 | PLIF Lordosis & Heights: 8° x 8-11mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Coll |