EZ-Track CAFB402008H

GUDID 00840314131324

LLIF INTERBODY CAGE, 20 X 40 X 8MM -7°

NEXT ORTHOSURGICAL, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840314131324
• NIH Device Record Key: f6481fd6-761d-41eb-afac-16e007ee6988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Track
• Version Model Number: CAFB402008H
• Catalog Number: CAFB402008H
• Company DUNS: 046767258
• Company Name: NEXT ORTHOSURGICAL, INC.
• 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

Device Dimensions

• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree
• Width: 20 Millimeter
• Length: 40 Millimeter
• Height: 8 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840314131324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131082

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

[00840314131324]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-09-03

On-Brand Devices [EZ-Track]

• 00840314136909: CERVICAL CAGE, FLAT, 14 X 12 X 5MM -0°
• 00840314134561: ALIF INTERBODY CAGE, 30 X 24 X 10MM -0°
• 00840314128027: LLIF INTERBODY CAGE, 18 X 40 X 8MM -0°
• 00840314122988: TLIF INTERBODY CAGE, 9 X 22 X 7MM -5°
• 00840314122506: OTLIF INTERBODY CAGE, 9 X 20 X 7MM -0°
• 00840314122186: PLIF INTERBODY CAGE, 9 X 30 X 7MM -5°
• 00840314102829: TLIF INTERBODY CAGE, 9 X 24 X 7MM -5°
• 00840314101389: OTLIF INTERBODY CAGE, 9 X 22 X 7MM -0°
• 00840314100429: PLIF INTERBODY CAGE, 9 X 22 X 7MM -5°
• 00840314100443: PLIF INTERBODY CAGE, 9 X 22 X 9MM -5°
• 00840314100436: PLIF INTERBODY CAGE, 9 X 22 X 8MM -5°
• 00840314101150: PLIF INTERBODY CAGE, 13 X 24 X 8MM -5°
• 00840314101143: PLIF INTERBODY CAGE, 13 X 24 X 7MM -5°
• 00840314101136: PLIF INTERBODY CAGE, 13 X 22 X 14MM -5°
• 00840314101129: PLIF INTERBODY CAGE, 13 X 22 X 13MM -5°
• 00840314101112: PLIF INTERBODY CAGE, 13 X 22 X 12MM -5°
• 00840314101105: PLIF INTERBODY CAGE, 13 X 22 X 11MM -5°
• 00840314101099: PLIF INTERBODY CAGE, 13 X 22 X 10MM -5°
• 00840314101082: PLIF INTERBODY CAGE, 13 X 22 X 9MM -5°
• 00840314101075: PLIF INTERBODY CAGE, 13 X 22 X 8MM -5°
• 00840314101068: PLIF INTERBODY CAGE, 13 X 22 X 7MM -5°
• 00840314101051: PLIF INTERBODY CAGE, 11 X 28 X 14MM -5°
• 00840314101044: PLIF INTERBODY CAGE, 11 X 28 X 13MM -5°
• 00840314101037: PLIF INTERBODY CAGE, 11 X 28 X 12MM -5°
• 00840314101020: PLIF INTERBODY CAGE, 11 X 28 X 11MM -5°
• 00840314101013: PLIF INTERBODY CAGE, 11 X 28 X 10MM -5°
• 00840314101006: PLIF INTERBODY CAGE, 11 X 28 X 9MM -5°
• 00840314100993: PLIF INTERBODY CAGE, 11 X 28 X 8MM -5°
• 00840314100986: PLIF INTERBODY CAGE, 11 X 28 X 7MM -5°
• 00840314100979: PLIF INTERBODY CAGE, 11 X 26 X 14MM -5°
• 00840314100962: PLIF INTERBODY CAGE, 11 X 26 X 13MM -5°
• 00840314100955: PLIF INTERBODY CAGE, 11 X 26 X 12MM -5°
• 00840314100948: PLIF INTERBODY CAGE, 11 X 26 X 11MM -5°
• 00840314100931: PLIF INTERBODY CAGE, 11 X 26 X 10MM -5°
• 00840314100924: PLIF INTERBODY CAGE, 11 X 26 X 9MM -5°
• 00840314100917: PLIF INTERBODY CAGE, 11 X 26 X 8MM -5°
• 00840314100900: PLIF INTERBODY CAGE, 11 X 26 X 7MM -5°
• 00840314100894: PLIF INTERBODY CAGE, 11 X 24 X 14MM -5°
• 00840314100887: PLIF INTERBODY CAGE, 11 X 24 X 13MM -5°
• 00840314100870: PLIF INTERBODY CAGE, 11 X 24 X 12MM -5°
• 00840314100863: PLIF INTERBODY CAGE, 11 X 24 X 11MM -5°
• 00840314100856: PLIF INTERBODY CAGE, 11 X 24 X 10MM -5°
• 00840314100849: PLIF INTERBODY CAGE, 11 X 24 X 9MM -5°
• 00840314100832: PLIF INTERBODY CAGE, 11 X 24 X 8MM -5°
• 00840314100825: PLIF INTERBODY CAGE, 11 X 24 X 7MM -5°
• 00840314100818: PLIF INTERBODY CAGE, 11 X 22 X 14MM -5°
• 00840314100801: PLIF INTERBODY CAGE, 11 X 22 X 13MM -5°
• 00840314100795: PLIF INTERBODY CAGE, 11 X 22 X 12MM -5°
• 00840314100788: PLIF INTERBODY CAGE, 11 X 22 X 11MM -5°
• 00840314100771: PLIF INTERBODY CAGE, 11 X 22 X 10MM -5°