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.

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00763000681432 - CD HORIZON® Spinal System2025-07-18 INSTRUMENT 7576305 REDUCTION INNER SLEEV
00763000681449 - CD HORIZON® Spinal System2025-07-18 INSTRUMENT 7576301 REDCTN OUTR EXTNDR ML
00763000681456 - CD HORIZON® Spinal System2025-07-18 INSTRUMENT 7576302 REDCTN MDL EXTNDR ML
00763000681463 - CD HORIZON® Spinal System2025-07-18 INSTRUMENT 7576303 REDUCTION EXTNDR A SL
00763000684426 - CD HORIZON® Spinal System2025-07-18 ROD 7575300 INSERTER
00763000684433 - CD HORIZON® Spinal System2025-07-18 75753059 INSTRUMENT EXTNDER INNER SLEEVE
00763000684440 - CD HORIZON® Spinal System2025-07-18 75753029 INSTRUMENT MULTILEVL MID EXTNDR

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