ARTiC-L Spinal System

GUDID 00763000085360

TRIAL 5251200 L 25 HT 12 DEG 0 FIXED

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00763000085360
NIH Device Record Key30e9f421-8865-45de-ba0d-9e46430a5674
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTiC-L Spinal System
Version Model Number5251200
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000085360 [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

[00763000085360]

Moist Heat or Steam Sterilization


[00763000085360]

Moist Heat or Steam Sterilization


[00763000085360]

Moist Heat or Steam Sterilization


[00763000085360]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-30
Device Publish Date2022-05-20

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00763000873233 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 PLATE G7731506 DIVERGENCE MINI 16.5MM
00763000873325 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 IMPLANT G7736527 MP LORDO 7MMX15MMX12MM
00763000885755 - Endoskeleton™ TT Interbody System with Titan nanoLOCK™ Surface Technology2025-06-24 NANO SPACER 4114-3509-N TT 4 DG XLG 9MM
00763000889135 - ATLANTIS® Anterior Cervical Plate System2025-06-24 SCREW 3120317 4.0 X 17 SELF TAP VAR
00763000889470 - ATLANTIS® Anterior Cervical Plate System2025-06-24 SCREW 3125513 4.5 X 13 SELF DRILL VAR
00763000873608 - DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM2025-06-24 SCREW PK2 G7733513 MINIP S-D 3.5MM X13MM
00199150000517 - Medtronic Reusable Instruments2025-06-23 INSERTER X468001500 CC 15DEG UP SHORT

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