VERTE-STACK Spinal System

GUDID 00613994305374

INSERTER 6246011 HANDLE OUTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic graft inserter
Primary Device ID00613994305374
NIH Device Record Key49547369-34ac-4bcc-b926-8ab7147b26d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERTE-STACK Spinal System
Version Model Number6246011
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994305374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


[00613994305374]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-28
Device Publish Date2021-12-20

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000864736 - T2 STRATOSPHERE™ Expandable Corpectomy System2025-03-31 INSERTER NAV4360120 20MM/25MM INSERTER
00199150001682 - Medtronic Reusable Instruments2025-03-28 ADAPTER EX5598045 BREAKOFF DRIVER
00763000987343 - Medtronic Reusable Instruments2025-03-28 DRIVER X5485903 MDLX REDUCER
00763000988395 - Medtronic Reusable Instruments2025-03-28 DRIVER X5598043 MDLX PROVISIONAL
00763000663506 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE 3002033 ZEVO 33MM 2 LVL
00763000663513 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE 3002035 ZEVO 35MM 2 LVL
00763000663872 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE G3003059 ZEVO 59MM 3 LVL
00763000663889 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE G3003061 ZEVO 61MM 3 LVL

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.