Primary Device ID | 00810076562131 |
NIH Device Record Key | ac675795-2899-4aea-a633-dda5be88209a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CervAlign Anterior Cervical Plate System |
Version Model Number | 66-4LVL-PLATE-CAD |
Catalog Number | 66-4LVL-PLATE-CAD |
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 | 00810076562131 [Primary] |
LRP | TRAY, SURGICAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
Moist Heat or Steam Sterilization
[00810076562131]
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 |