| Primary Device ID | B707129410010010 |
| NIH Device Record Key | b9ad6d08-f146-4e68-b1ec-80f6fe26fb1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALXS T/PLIF 12 DEG x 7-10MM |
| Version Model Number | 12941001001 |
| 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 |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com | |
| Phone | 7652675439 |
| udi@amplifysurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B707129410010010 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
[B707129410010010]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-05-21 |
| Device Publish Date | 2023-01-10 |
| B707129410010050 | Lordosis & Heights: 8° x 7-10mm Collapsed Width (mm): 12 Expanded Width (mm): 20 Collapsed Heig |
| B707129410010010 | Lordosis & Heights: 12° x 7-10mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Hei |