FDA.reportPublic FDA data

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

Primary DI
00643169800472
Brand
ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
53301825
Device description
SPACER 53301825 30MM X 18MM 25 DEGREE TI
Published
2017-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171689000ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC TechnologyMedtronic Sofamor Danek USA, Inc.2017-10-05MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169800472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169800472006431698004726431698004720643169800472

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
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00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
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00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04251631420347NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
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04251631420361NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
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