CervAlign Anterior Cervical Plate System 66-1LVL-PLATE-CAD

GUDID 00810076562100

1-LVL PLATE CADDY

Xtant Medical Holdings, Inc.

Device sterilization/disinfection container, reusable
Primary Device ID00810076562100
NIH Device Record Key718a0502-5a2a-4737-9a1f-39cab330816a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervAlign Anterior Cervical Plate System
Version Model Number66-1LVL-PLATE-CAD
Catalog Number66-1LVL-PLATE-CAD
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810076562100 [Primary]

FDA Product Code

LRPTRAY, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


[00810076562100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-12
Device Publish Date2025-06-04

On-Brand Devices [CervAlign Anterior Cervical Plate System]

00810076562155Screw Caddy, Cervalign
008100765621485-LVL Plate Caddy, Cervalign
008100765621314-LVL Plate Caddy, Cervalign
008100765621243-LVL Plate Caddy, Cervalign
008100765621172-LVL Plate Caddy, Cervalign
008100765621001-LVL PLATE CADDY
00810076562094Caddy Case, Cervalign
00810076562087CASE
00810076562070Temporary Plate Holding Threaded Pin
00810076562056Temporary Plate Holding Push Pin

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