FDA.reportPublic FDA data

ANTARES Standalone ALIF System

Primary DI
00810116510108
Brand
ANTARES Standalone ALIF System
Company
MIRUS LLC
Model
010-L-1608
Device description
ANTARES W40 X D30 X H16 mm, 08° SA ALIF
Published
2025-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220115000ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC2022-05-13OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116510108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116510108008101165101088101165101080810116510108

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080311078
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810116510009ANTARES Standalone ALIF System010-L-11082025-12-04
00810116510016ANTARES Standalone ALIF System010-L-12082025-12-04
00810116510023ANTARES Standalone ALIF System010-L-12122025-12-04
00810116510030ANTARES Standalone ALIF System010-L-13082025-12-04
00810116510047ANTARES Standalone ALIF System010-L-13122025-12-04
00810116510054ANTARES Standalone ALIF System010-L-13162025-12-04
00810116510061ANTARES Standalone ALIF System010-L-14082025-12-04
00810116510078ANTARES Standalone ALIF System010-L-14122025-12-04
00810116510085ANTARES Standalone ALIF System010-L-14162025-12-04
00810116510092ANTARES Standalone ALIF System010-L-14202025-12-04
00810116510115ANTARES Standalone ALIF System010-L-16122025-12-04
00810116510122ANTARES Standalone ALIF System010-L-16162025-12-04
00810116510139ANTARES Standalone ALIF System010-L-16202025-12-04
00810116510146ANTARES Standalone ALIF System010-L-16252025-12-04
00810116510153ANTARES Standalone ALIF System010-L-18082025-12-04
00810116510160ANTARES Standalone ALIF System010-L-18122025-12-04
00810025487706IO™ Expandable Lumbar Interbody System6-1022-L2023-01-27
00810025487713IO™ Expandable Lumbar Interbody System6-1222-L2023-01-27
00810025487720IO™ Expandable Lumbar Interbody System6-1026-L2023-01-27
00810025487737IO™ Expandable Lumbar Interbody System6-1226-L2023-01-27

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Primary DI, Brand, Company table
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