Axis Spine Technologies ALIF

GUDID 05060771804189

ALIF Screw H20 - 27.5mm

AXIS SPINE TECHNOLOGIES LTD

Metallic spinal interbody fusion cage
Primary Device ID05060771804189
NIH Device Record Key97a9ab7e-73cb-4e6f-a048-1cf8728f4393
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxis Spine Technologies ALIF
Version Model NumberA5240275
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060771804189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


[05060771804189]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-17
Device Publish Date2021-02-09

On-Brand Devices [Axis Spine Technologies ALIF]

05060771804431ALIF Superior Endplate Coronal Right - Large
05060771804417ALIF Superior Endplate Coronal Right - Medium
05060771804318ALIF Superior Endplate Coronal Left - Large
05060771804295ALIF Superior Endplate Coronal Left - Medium
05060771804257ALIF Inferior Endplate Hyper Lordotic - Large
05060771804233ALIF Inferior Endplate Hyper Lordotic - Medium
05060771804219ALIF Screw H20 - 35mm
05060771804202ALIF Screw H20 - 32.5mm
05060771804196ALIF Screw H20 - 30mm
05060771804189ALIF Screw H20 - 27.5mm
05060771804172ALIF Screw H20 - 25mm
05060771802703ALIF Cover Plate M/L 8 x 30
05060771802680ALIF Cover Plate M/L 6 x 30
05060771802581ALIF Cover Plate M/L 8 x 25
05060771802567ALIF Cover Plate M/L 6 x 25
05060771802482ALIF Cover Plate M/L 10 x 20
05060771802468ALIF Cover Plate M/L 8 x 20
05060771802444ALIF Cover Plate M/L 6 x 20
05060771802369ALIF Cover Plate M/L 10 x 15
05060771802345ALIF Cover Plate M/L 8 x 15
05060771802321ALIF Cover Plate M/L 6 x 15
05060771802246ALIF Cover Plate M/L 10 x 10
05060771802222ALIF Cover Plate M/L 8 x 10
05060771802208ALIF Cover Plate M/L 6 x10
05060771801652ALIF Screw T20 - 35mm
05060771801638ALIF Screw T20 - 32.5mm
05060771801621ALIF Screw T20 - 30mm
05060771801614ALIF Screw T20 - 27.5mm
05060771801607ALIF Screw T20 - 25mm
05060771801225ALIF Core M/L 8 x 30
05060771801201ALIF Core M/L 6 x 30
05060771801164ALIF Core M/L 8 x 25
05060771801140ALIF Core M/L 6 x 25
05060771801126ALIF Core M/L 10 x 20
05060771801102ALIF Core M/L 8 x 20
05060771801089ALIF Core M/L 6 x 20
05060771801065ALIF Core M/L 10 x 15
05060771801041ALIF Core M/L 8 x 15
05060771801027ALIF Core M/L 6 x 15
05060771801003ALIF Core M/L 10 x 10
05060771800983ALIF Core M/L 8 x 10
05060771800969ALIF Core M/L 6 x10
05060771800402ALIF Inferior Endplate Coronal Right - Large
05060771800389ALIF Inferior Endplate Coronal Right - Medium
05060771800280ALIF Inferior Endplate Coronal Left - Large
05060771800266ALIF Inferior Endplate Coronal Left - Medium
05060771800228ALIF Superior Endplate Hyper Lordotic - Large
05060771800204ALIF Superior Endplate Hyper Lordotic - Medium
05060771800105ALIF Inferior Endplate - Large
05060771800082ALIF Inferior Endplate - Medium

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