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.

00643169731059 - Medtronic Transportation/Sterilization Cassette2025-04-28 TRAY 7068060T IMPLANT INSTRUMENT 5.5/6.0
00721902766138 - MSB General Instruments2025-04-28 INSTRUMENT 6276010 FORK HAMMER
00763000662882 - ZEVO™ Anterior Cervical Plate System2025-04-28 SCREW 7713519 ZEVO VAR SD 3.5MM X 19MM
00885074371191 - MSB General Instruments2025-04-28 BLOCK 6279005 PSR LOADING
00885074515700 - CD HORIZON® Spinal System2025-04-28 HOOK, PEDICLE, MD, TI
00763000663421 - ZEVO™ Anterior Cervical Plate System2025-04-25 PLATE 3001023 ZEVO 23MM 1 LVL
00763000848583 - CD Horizon™ ModuLeX™ Spinal System2025-04-25 UAS/SS 559200095 5.5 TI VOYAGER 4 PK
00763000787820 - CD HORIZON® Spinal System2025-04-22 ROD 8672045 SEXTANT 45MM TI

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