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

GUDID 00643169933774

TRIAL 5350805 L 35 HT 8 DEG 5 ART

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00643169933774
NIH Device Record Keya264f4cd-b3fa-4c93-b48c-e247eef57462
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology
Version Model Number5350805
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
GS100643169933774 [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

[00643169933774]

Moist Heat or Steam Sterilization


[00643169933774]

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-L™ 3D Ti Spinal System with TiONIC™ Technology]

00643169933798TRIAL 5350800 L 35 HT 8 DEG 0 FIXED
00643169933781TRIAL 5300800 L 30 HT 8 DEG 0 FIXED
00643169933774TRIAL 5350805 L 35 HT 8 DEG 5 ART
00643169933767TRIAL 5300805 L 30 HT 8 DEG 5 ART
00643169858534TRAY 5332036 TI INTRABODY FIXED TRIALS
00643169858527LID 5332035 TI TLIF ARTICULATING TRIALS
00643169858510CADDY 5332034 TI TLIF ARTICULATING TRIAL
00643169858503TRAY 5332033 TI TLIF ARTICULATING TRIALS
00643169801493SPACER 56351510 12W 35MM X 15MM 10 DG TI
00643169801486SPACER 56351410 12W 35MM X 14MM 10 DG TI
00643169801479SPACER 56351310 12W 35MM X 13MM 10 DG TI
00643169801462SPACER 56351210 12W 35MM X 12MM 10 DG TI
00643169801455SPACER 56351110 12W 35MM X 11MM 10 DG TI
00643169801448SPACER 56351010 12W 35MM X 10MM 10 DG TI
00643169801431SPACER 56350910 12W 35MM X 9MM 10 DG TI
00643169801424SPACER 56350810 12W 35MM X 8MM 10 DG TI
00643169801417SPACER 56301510 12W 30MM X 15MM 10 DG TI
00643169801400SPACER 56301410 12W 30MM X 14MM 10 DG TI
00643169801394SPACER 56301310 12W 30MM X 13MM 10 DG TI
00643169801387SPACER 56301210 12W 30MM X 12MM 10 DG TI
00643169801370SPACER 56301110 12W 30MM X 11MM 10 DG TI
00643169801363SPACER 56301010 12W 30MM X 10MM 10 DG TI
00643169801356SPACER 56300910 12W 30MM X 9MM 10 DG TI
00643169801349SPACER 56300810 12W 30MM X 8MM 10 DG TI
00643169801332SPACER 56251510 12W 25MM X 15MM 10 DG TI
00643169801325SPACER 56251410 12W 25MM X 14MM 10 DG TI
00643169801318SPACER 56251310 12W 25MM X 13MM 10 DG TI
00643169801301SPACER 56251210 12W 25MM X 12MM 10 DG TI
00643169801295SPACER 56251110 12W 25MM X 11MM 10 DG TI
00643169801288SPACER 56251010 12W 25MM X 10MM 10 DG TI
00643169801271SPACER 56250910 12W 25MM X 9MM 10 DG TI
00643169801264SPACER 56250810 12W 25MM X 8MM 10 DG TI
00643169801257SPACER 56351505 12W 35MM X 15MM 5 DG TI
00643169801240SPACER 56351405 12W 35MM X 14MM 5 DG TI
00643169801233SPACER 56351305 12W 35MM X 13MM 5 DG TI
00643169801219SPACER 56351105 12W 35MM X 11MM 5 DG TI
00643169801202SPACER 56351005 12W 35MM X 10MM 5 DG TI
00643169801196SPACER 56350905 12W 35MM X 9MM 5 DG TI
00643169801189SPACER 56350805 12W 35MM X 8MM 5 DG TI
00643169801165SPACER 56301505 12W 30MM X 15MM 5 DG TI
00643169801158SPACER 56301405 12W 30MM X 14MM 5 DG TI
00643169801141SPACER 56301305 12W 30MM X 13MM 5 DG TI
00643169801134SPACER 56301205 12W 30MM X 12MM 5 DG TI
00643169801127SPACER 56301105 12W 30MM X 11MM 5 DG TI
00643169801110SPACER 56301005 12W 30MM X 10MM 5 DG TI
00643169801103SPACER 56300905 12W 30MM X 9MM 5 DG TI
00643169801073SPACER 56251505 12W 25MM X 15MM 5 DG TI
00643169801066SPACER 56251405 12W 25MM X 14MM 5 DG TI
00643169801059SPACER 56251305 12W 25MM X 13MM 5 DG TI
00643169801042SPACER 56251205 12W 25MM X 12MM 5 DG TI

Trademark Results [ARTiC-L]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARTIC-L
ARTIC-L
87290814 5638538 Live/Registered
Warsaw Orthopedic, Inc.
2017-01-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.