| Primary Device ID | 00840311258048 |
| NIH Device Record Key | ec2f7e49-e4d5-4e28-80e1-5bb5121ad958 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MIS Fusion Instruments |
| Version Model Number | 38-THANDLE |
| 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 | |
| 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 | 00840311258048 [Primary] |
| GS1 | 00846468040673 [Previous] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
[00840311258048]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-03 |
| Device Publish Date | 2025-09-25 |
| 00840311258055 - Streamline TL Spinal Fixation System | 2025-10-06 T-HANDLE |
| 00840311258048 - MIS Fusion Instruments | 2025-10-03T-Handle, Hudson |
| 00840311258048 - MIS Fusion Instruments | 2025-10-03 T-Handle, Hudson |
| 00840311257942 - Streamline TL Spinal Fixation System | 2025-09-30 ROD TEMPLATE |
| 00840311257935 - Streamline TL Spinal Fixation System | 2025-09-26 T-HANDLE, RATCHETING |
| 00840311257867 - Cortera Spinal Fixation System | 2025-09-03 TAB SPLITTER, DOUBLE ACTION |
| 00840311253494 - Cortera Spinal Fixation System | 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 11mm |
| 00840311253500 - Cortera Spinal Fixation System | 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 15mm |
| 00840311253517 - Cortera Spinal Fixation System | 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 19mm |