ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology

GUDID 00643169800489

SPACER 53301535 30MM X 15MM 35 DEGREE TI

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00643169800489
NIH Device Record Key640f0a91-4710-46a8-a855-336f4db15bf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology
Version Model Number53301535
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169800489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-10-27

On-Brand Devices [ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology]

00643169844209TRAY 5332030 TI INTERBODY INSTRUMENTS
00643169800595SPACER 53501835 50MM X 18MM 35 DEGREE TI
00643169800588SPACER 53501535 50MM X 15MM 35 DEGREE TI
00643169800571SPACER 53501825 50MM X 18MM 25 DEGREE TI
00643169800564SPACER 53501525 50MM X 15MM 25 DEGREE TI
00643169800557SPACER 53501225 50MM X 12MM 25 DEGREE TI
00643169800540SPACER 53401835 40MM X 18MM 35 DEGREE TI
00643169800533SPACER 53401535 40MM X 15MM 35 DEGREE TI
00643169800526SPACER 53401825 40MM X 18MM 25 DEGREE TI
00643169800519SPACER 53401525 40MM X 15MM 25 DEGREE TI
00643169800502SPACER 53401225 40MM X 12MM 25 DEGREE TI
00643169800496SPACER 53301835 30MM X 18MM 35 DEGREE TI
00643169800489SPACER 53301535 30MM X 15MM 35 DEGREE TI
00643169800472SPACER 53301825 30MM X 18MM 25 DEGREE TI
00643169800465SPACER 53301525 30MM X 15MM 25 DEGREE TI
00643169800458SPACER 53301225 30MM X 12MM 25 DEGREE TI
00763000086305TRAY 5332030 TI INTERBODY INSTRUMENTS

Trademark Results [ARTiC-XL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARTIC-XL
ARTIC-XL
87303941 not registered Live/Pending
Warsaw Orthopedic, Inc.
2017-01-17
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