FDA.reportPublic FDA data

Axis Spine Technologies ALIF

Primary DI
05060771803403
Brand
Axis Spine Technologies ALIF
Company
AXIS SPINE TECHNOLOGIES LTD
Model
A6070300
Device description
ALIF Endplate Sizer
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
05060771803403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060771803403050607718034035060771803403

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
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00197157074142ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074159ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074173ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074203ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074227ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074234ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074258ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074333ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29