ARTiC-XL™ Spinal System

GUDID 00643169838048

TRIAL 54401525 L 40 HT 15 DEG 25

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00643169838048
NIH Device Record Keyfbae52ba-0d35-442e-a074-dc67b1fa99a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTiC-XL™ Spinal System
Version Model Number54401525
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169838048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169838048]

Moist Heat or Steam Sterilization


[00643169838048]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-10-27

On-Brand Devices [ARTiC-XL™ Spinal System]

00643169838123TRIAL 54501835 L 50 HT 18 DEG 35
00643169838116TRIAL 54501535 L 50 HT 15 DEG 35
00643169838109TRIAL 54501825 L 50 HT 18 DEG 25
00643169838093TRIAL 54501525 L 50 HT 15 DEG 25
00643169838086TRIAL 54501225 L 50 HT 12 DEG 25
00643169838079TRIAL 54401835 L 40 HT 18 DEG 35
00643169838062TRIAL 54401535 L 40 HT 15 DEG 35
00643169838055TRIAL 54401825 L 40 HT 18 DEG 25
00643169838048TRIAL 54401525 L 40 HT 15 DEG 25
00643169838031TRIAL 54401225 L 40 HT 12 DEG 25
00643169838024TRIAL 54301835 L 30 HT 18 DEG 35
00643169838000TRIAL 54301825 L 30 HT 18 DEG 25
00643169837997TRIAL 54301525 L 30 HT 15 DEG 25
00643169837980TRIAL 54301225 L 30 HT 12 DEG 25
00643169838017TRIAL 54301535 L 30 HT 15 DEG 35

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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