EZ-Track CJAB141205A

GUDID 00840314136909

CERVICAL CAGE, FLAT, 14 X 12 X 5MM -0°

NEXT ORTHOSURGICAL, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840314136909
• NIH Device Record Key: 6e978bec-dab7-4893-a21d-483d1d57ed8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Track
• Version Model Number: CJAB141205A
• Catalog Number: CJAB141205A
• 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

Customer Support Contacts

• Phone: 760-295-3600
• Email: info@nextorthosurgical.com

Device Dimensions

• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840314136909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161608

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00840314136909]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-04-29

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°