Streamline TL Spinal Fixation System 10-TEMPLATE-400

GUDID 00840311257942

ROD TEMPLATE

Xtant Medical Holdings, Inc.

Surgical implant template, reusable
Primary Device ID00840311257942
NIH Device Record Key6dc69af0-64bd-4b35-b243-8fb52359712a
Commercial Distribution StatusIn Commercial Distribution
Brand NameStreamline TL Spinal Fixation System
Version Model Number10-TEMPLATE-400
Catalog Number10-TEMPLATE-400
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 Usefalse
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
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311257942 [Primary]
GS100846468001766 [Previous]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


[00840311257942]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

On-Brand Devices [Streamline TL Spinal Fixation System]

00840311257935T-HANDLE, RATCHETING
00840311257942ROD TEMPLATE

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