FDA.reportPublic FDA data

Axis Spine Technologies ALIF

Primary DI
05060771803229
Brand
Axis Spine Technologies ALIF
Company
AXIS SPINE TECHNOLOGIES LTD
Model
A6060825
Device description
ALIF Core Trial - 8x25
Published
2021-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K200352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200352000Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.2020-05-20OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060771803229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060771803229050607718032295060771803229

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+443301230535enquiries@axisspinetech.com

Regulatory Flags#

DUNS number
221947288
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056619802813Axis Spine Technologies ALIF1984-00-3202025-12-16
05056619802820Axis Spine Technologies ALIF1984-00-3212025-12-16
05056619802837Axis Spine Technologies ALIF1984-00-3602025-12-16
05056619802844Axis Spine Technologies ALIF1984-00-3652025-12-16
05056619802851Axis Spine Technologies ALIF1984-00-3852025-12-16
05056619802868Axis Spine Technologies ALIF1984-00-4202025-12-16
05056619802875Axis Spine Technologies ALIF1984-00-4212025-12-16
05056619802882Axis Spine Technologies ALIF1984-00-4602025-12-16
05056619802899Axis Spine Technologies ALIF1984-00-4652025-12-16
05056619801762Axis Spine Technologies ALIF System InstrumentAI-6010.2AI-6010.22024-11-20
05056619801779Axis Spine Technologies ALIF System InstrumentAI-6011AI-60112024-11-20
05056619801786Axis Spine Technologies ALIF System InstrumentAI-6012.1AI-6012.12024-11-20
05056619801793Axis Spine Technologies ALIF System InstrumentAI-6012.2AI-6012.22024-11-20
05056619801809Axis Spine Technologies ALIF System InstrumentAI-6010.1AI-6010.12024-11-20
05056619801069Axis Spine Technologies ALIF System InstrumentA6200325A62003252024-06-13
05056619801076Axis Spine Technologies ALIF System InstrumentA6200375A62003752024-06-13
05056619801083Axis Spine Technologies ALIF System InstrumentA6200525A62005252024-06-13
05056619801090Axis Spine Technologies ALIF System InstrumentGI-9010GI-90102024-06-13
05056619801106Axis Spine Technologies ALIF System InstrumentGI-9015GI-90152024-06-13
05056619801113Axis Spine Technologies ALIF System InstrumentGI-9020GI-90202024-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982313524ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313531ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313548ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313555ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00193982313562ELSAGLOBUS MEDICAL, INC.OVD2026-08-14
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2026-08-14
00889095311532INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311549INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311556INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311563INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311570INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
00889095311587INDEPENDENCE MISGLOBUS MEDICAL, INC.OVD2026-08-14
03700780640195Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
03700780654611Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511781MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19