FDA.reportPublic FDA data

Axis Spine Technologies ALIF

Primary DI
05060771803205
Brand
Axis Spine Technologies ALIF
Company
AXIS SPINE TECHNOLOGIES LTD
Model
A6060625
Device description
ALIF Core Trial - 6x25
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
05060771803205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060771803205050607718032055060771803205

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
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046202AVS PLStryker CorporationOVD2015-09-14
07613153046219AVS PLStryker CorporationOVD2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046233AVS PLStryker CorporationOVD2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046301AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046325AVS PLStryker CorporationOVD2015-09-14
07613153046332AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14