Axis Spine Technologies ALIF

GUDID 05060771800969

ALIF Core M/L 6 x10

AXIS SPINE TECHNOLOGIES LTD

Metallic spinal interbody fusion cage

• Primary Device ID: 05060771800969
• NIH Device Record Key: dd846f9c-e0a2-4bec-aca5-2f6e76020226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axis Spine Technologies ALIF
• Version Model Number: A3206100
• Company DUNS: 221947288
• Company Name: AXIS SPINE TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com
• Phone: +443301230535
• Email: enquiries@axisspinetech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060771800969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200352

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

[05060771800969]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [Axis Spine Technologies ALIF]

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