| Primary Device ID | 00840311257928 |
| NIH Device Record Key | c04a625a-73ca-4a2a-b7d8-46b86868eddf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STREAMLINE OCT |
| Version Model Number | C999-000004 |
| 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 | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com | |
| Phone | 1-888-886-9354 |
| CS@xtantmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311257928 [Primary] |
| FZT | Cutter, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-19 |
| Device Publish Date | 2025-08-11 |
| 00840311252237 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, SAGITTAL, 5.5, RIGHT |
| 00840311252244 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, SAGITTAL, 5.5, LEFT |
| 00840311252251 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, SAGITTAL, 6.0, RIGHT |
| 00840311252268 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, SAGITTAL, 6.0, LEFT |
| 00840311252275 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, CORONAL, 5.5, RIGHT |
| 00840311252282 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, CORONAL, 5.5, LEFT |
| 00840311252299 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, CORONAL, RACK |
| 00840311252305 - Cortera Spinal Fixation System | 2025-11-28 ROD BENDER, CORONAL, 6.0, RIGHT |