| Primary Device ID | 00810076562056 |
| NIH Device Record Key | 165fad0a-6149-47e3-abfe-bd267ae8aeef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CervAlign Anterior Cervical Plate System |
| Version Model Number | 66-PUSHPIN |
| Catalog Number | 66-PUSHPIN |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810076562056 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
[00810076562056]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-12 |
| Device Publish Date | 2025-06-04 |
| 00810076562155 | Screw Caddy, Cervalign |
| 00810076562148 | 5-LVL Plate Caddy, Cervalign |
| 00810076562131 | 4-LVL Plate Caddy, Cervalign |
| 00810076562124 | 3-LVL Plate Caddy, Cervalign |
| 00810076562117 | 2-LVL Plate Caddy, Cervalign |
| 00810076562100 | 1-LVL PLATE CADDY |
| 00810076562094 | Caddy Case, Cervalign |
| 00810076562087 | CASE |
| 00810076562070 | Temporary Plate Holding Threaded Pin |
| 00810076562056 | Temporary Plate Holding Push Pin |