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.

00763000857189 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277541 CORNERSTONE PSR 5X14X11MM
00763000857196 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277641 CORNERSTONE PSR 6X14X11MM
00763000857202 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277741 CORNERSTONE PSR 7X14X11MM
00763000857219 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277841 CORNERSTONE PSR 8X14X11MM
00763000857226 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277941 CORNERSTONE PSR 9X14X11MM
00763000857509 - VERTE-STACK® Spinal System2025-02-21 SPACER 6287241 PSR LAT PORTS 12X14X11
00763000857516 - VERTE-STACK® Spinal System2025-02-21 SPACER 6287341 PSR LAT PORTS 13X14X11
00763000857547 - VERTE-STACK® Spinal System2025-02-21 SPACER 6287741 PSR LAT PORTS 7X14X11

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