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

GUDID 00763000085537

SPACER 56301105 12W 30MM X 11MM 5 DG TI

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00763000085537
• NIH Device Record Key: d4d629f4-d3ca-4377-9cad-c5cc0a248164
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology
• Version Model Number: 56301105
• 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	00763000085537 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-08
• Device Publish Date: 2018-09-07

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