VERTE-STACK®

GUDID 00763000857561

SPACER 6287941 PSR LAT PORTS 9X14X11

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis
Primary Device ID00763000857561
NIH Device Record Key3dc6eee8-1c5a-4ee5-9e10-5302f9c11b70
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERTE-STACK®
Version Model Number6287941
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 Usetrue
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

Device Dimensions

Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter
Height14 Millimeter
Width9 Millimeter
Depth11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000857561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-07
Device Publish Date2025-03-28

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00643169571839 - RIALTO™ SI FUSION SYSTEM2025-05-16 DEVICE 74200001245 THREADED 12X45
00763000880101 - n/a2025-05-16 INSERTER 7967012 CP
00643169500365 - CD HORIZON® Growth Rod Conversion Set2025-05-13 CONNECTOR 811212GR 110MM TI 5.5MM ROD S
00763000878016 - n/a2025-05-13 RASP 6630919 PARALLEL 10MMX15MMX12MM
00763000878047 - n/a2025-05-13 RASP 6630916 PARALLEL 7MMX15MMX12MM
00763000891367 - CD Horizon™ ModuLeX™ Spinal System2025-05-13 SHANK 55900608510 ILIAC 8.5X110MM
00763000891381 - CD Horizon™ ModuLeX™ Spinal System2025-05-13 SHANK 55900608560 ILIAC 8.5X60MM
00763000280468 - CENTERPIECE™ Plate Fixation System2025-05-12 TRAY 8530107R CENTERPIECE INSTRUMENTS

Trademark Results [VERTE-STACK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERTE-STACK
VERTE-STACK
78100037 2774125 Dead/Cancelled
MEDTRONIC SOFAMOR DANEK INC.
2001-12-27
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.