| Primary Device ID | 00840311262700 |
| NIH Device Record Key | a5da235a-7239-4fad-97be-3ee43d313c6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CASE, OUTER, LID |
| Version Model Number | 434-224 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311262700 [Primary] |
| LRP | Tray, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
[00840311262700]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-19 |
| Device Publish Date | 2026-02-11 |
| 00840311262694 - CASE, OUTER, DOUBLE LEVEL | 2026-02-19 CASE, OUTER, DOUBLE LEVEL |
| 00840311262700 - CASE, OUTER, LID | 2026-02-19CASE, OUTER, LID |
| 00840311262700 - CASE, OUTER, LID | 2026-02-19 CASE, OUTER, LID |
| 00840311247318 - Fortilink | 2026-01-30 TiPlus-TC Inserter, Straight |
| 00840311262670 - Cortera Spinal Fixation System | 2025-12-30 Caddy, Set Screw, 5.5-6.0 |
| 00840311262687 - Cortera Spinal Fixation System | 2025-12-30 Lid, Set Screw, 5.5-6.0 |
| 00840311262663 - Streamline TL Spinal Fixation System | 2025-12-25 Streamline TL, 8.5mm Long Screw Caddy |
| 00840311262632 - Fusion™ Posterior Instrument Set | 2025-12-19 VBR, Graft Funnel |
| 00840311244713 - Cortera Spinal Fixation System | 2025-12-18 NAV Instruments Set, ASM |