| Primary Device ID | B707125354010050 |
| NIH Device Record Key | 1a82dc19-088b-4d1a-8709-e9460cd33667 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUALX TLIF TRIAL 10-13MM |
| Version Model Number | 12535401005 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | B707125354010050 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
[B707125354010050]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
| B70712535200004A0 | DUALX TLIF TRIAL 10-13MM |
| B707125352000040 | DUALX TLIF TRIAL 10-13MM Rev D |
| B707125354000050 | DUALX TLIF TRIAL 10-13MM |
| B707125354010050 | DUALX TLIF TRIAL 10-13MM |