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

GUDID 00643169800748

SPACER 56351220 12W 35MM X 12MM 20 DG TI

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

Primary Device ID	00643169800748
NIH Device Record Key	3d462613-7cb7-4d4a-8d76-1a69abc7e963
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology
Version Model Number	56351220
Company DUNS	830350380
Company Name	MEDTRONIC SOFAMOR DANEK, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169800748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171689

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-21
Device Publish Date	2017-10-27

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

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