FDA.reportPublic FDA data

Axis Spine Technologies ALIF System Instrument

Primary DI
05056619801106
Brand
Axis Spine Technologies ALIF System Instrument
Company
AXIS SPINE TECHNOLOGIES LTD
Model
GI-9015
Catalog number
GI-9015
Device description
T-Handle Ratchet
Published
2024-06-13
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056619801106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056619801106050566198011065056619801106

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
05056619801113Axis Spine Technologies ALIF System InstrumentGI-9020GI-90202024-06-13
05056619801120Axis Spine Technologies ALIF System InstrumentGI-9025GI-90252024-06-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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