| Primary Device ID | 00840311257942 |
| NIH Device Record Key | 6dc69af0-64bd-4b35-b243-8fb52359712a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Streamline TL Spinal Fixation System |
| Version Model Number | 10-TEMPLATE-400 |
| Catalog Number | 10-TEMPLATE-400 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com | |
| Phone | 888-886-9354 |
| cs@xtantmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311257942 [Primary] |
| GS1 | 00846468001766 [Previous] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
[00840311257942]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-30 |
| Device Publish Date | 2025-09-22 |
| 00840311257935 | T-HANDLE, RATCHETING |
| 00840311257942 | ROD TEMPLATE |
| 00840311258055 | T-HANDLE |