Axis Spine Technologies ALIF System Instrument AI-4810

GUDID 05056619801533

DH Inserter - Core Trial - 8x10

AXIS SPINE TECHNOLOGIES LTD

Spinal implant trial
Primary Device ID05056619801533
NIH Device Record Key277ccfa7-11af-429d-bb15-8c5129e7c7b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxis Spine Technologies ALIF System Instrument
Version Model NumberAI-4810
Catalog NumberAI-4810
Company DUNS221947288
Company NameAXIS SPINE TECHNOLOGIES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com
Phone+443301230535
Emailenquiries@axisspinetech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056619801533 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


[05056619801533]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-21
Device Publish Date2024-06-13

On-Brand Devices [Axis Spine Technologies ALIF System Instrument]

05060771809900ALIF Endplate Alignment Tool
05060771809894Disc Spreader Tip (Medium Straight)
05060771809887Disc Spreader Tip (Small Straight)
05060771809870ALIF Slim Tamp
05060771809863Disc Spreader
05060771809672Disc Spreader Tip (Medium Angled Right)
05060771809665Disc Spreader Tip (Medium Angled Left)
05060771809658Disc Spreader Tip (Small Angled Right)
05060771809641Disc Spreader Tip (Small Angled Left)
05060771809597ALIF Graft Tamp
05060771809580ALIF Loading Block
05060771809207T Handle (Sq)
05060771808712ALIF Endplate Sizer Large Slim
05060771808705ALIF Endplate Sizer Small Slim
05060771808699ALIF Endplate Sizer Medium Slim
05060771807760ALIF Tamp
05060771806534ALIF Blocker Plate Remover
05060771806510ALIF Inserter (Superior)
05060771806473ALIF Core Trial - 8x30
05060771806459ALIF Core Trial - 6x30
05060771806350ALIF Core Trial - 8x25
05060771806336ALIF Core Trial - 6x25
05060771806251ALIF Core Trial - 10x20
05060771806237ALIF Core Trial - 8x20
05060771806213ALIF Core Trial - 6x20
05060771806138ALIF Core Trial - 10x15
05060771806114ALIF Core Trial - 8x15
05060771806091ALIF Core Trial - 6x15
05060771806015ALIF Core Trial - 10x10
05060771805995ALIF Core Trial - 8x10
05060771805971ALIF Core Trial - 6x10
05060771804608ALIF Endplate Sizer Large
05060771804592ALIF Endplate Sizer Small
05060771804585ALIF Endplate Sizer Medium
05060771804110Straight Handle (Small AO)
05060771804103ALIF Angled Screw Inserter Anti-Torque
05060771804042ALIF Angled Screw Inserter
05060771804028ALIF Screwdriver
05060771804011T-Handle Small AO
05060771803748ALIF Graft Syringe Medium
05060771803588ALIF Slap Hammer
05060771803502ALIF Graft Syringe Small
05056619801052ALIF Core Loader
05056619801045Paddle Distractor 12mm
05056619801038Slotted Mallet
05056619801007ALIF Curved Awl Long
05056619800994ALIF Core Trial Inserter
05056619800826ALIF Inserter Inferior
05056619800819ALIF Inserter Superior
05056619800802Disc Spreader Tip (Laminar Angled Right)

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