VERTE-STACK Spinal System

GUDID 00763000671525

INSERTER 6246011 HANDLE OUTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic graft inserter, reusable
Primary Device ID00763000671525
NIH Device Record Key212053d8-6067-4e2b-a0f8-fb07a9dd46dc
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000671525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


[00763000671525]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-04
Device Publish Date2025-07-27

On-Brand Devices [VERTE-STACK Spinal System]

00613994305374INSERTER 6246011 HANDLE OUTER
00763000671525INSERTER 6246011 HANDLE OUTER

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