Anterior Cervical IBFD EX AC4-121410-07

GUDID B084AC4121410070

KEOS

Polymeric spinal interbody fusion cage

• Primary Device ID: B084AC4121410070
• NIH Device Record Key: 119d3303-fd2b-452a-bbfa-572fb11e41df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Cervical IBFD EX
• Version Model Number: 12D x 14W x 10H x 7L, PEEK-HA
• Catalog Number: AC4-121410-07
• Company DUNS: 080551837
• Company Name: KEOS
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B084AC4121410070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212450

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

[B084AC4121410070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [Anterior Cervical IBFD EX]

• B084AC4141612070: 14D x 16W x 12H x 7L, PEEK-HA
• B084AC4141611070: 14D x 16W x 11H x 7L, PEEK-HA
• B084AC4141610070: 14D x 16W x 10H x 7L, PEEK-HA
• B084AC4141609070: 14D x 16W x 09H x 7L, PEEK-HA
• B084AC4141608070: 14D x 16W x 08H x 7L, PEEK-HA
• B084AC4141607070: 14D x 16W x 07H x 7L, PEEK-HA
• B084AC4141606070: 14D x 16W x 06H x 7L, PEEK-HA
• B084AC4141605070: 14D x 16W x 05H x 7L, PEEK-HA
• B084AC4121412070: 12D x 14W x 12H x 7L, PEEK-HA
• B084AC4121411070: 12D x 14W x 11H x 7L, PEEK-HA
• B084AC4121410070: 12D x 14W x 10H x 7L, PEEK-HA
• B084AC4121409070: 12D x 14W x 09H x 7L, PEEK-HA
• B084AC4121408070: 12D x 14W x 08H x 7L, PEEK-HA
• B084AC4121407070: 12D x 14W x 07H x 7L, PEEK-HA
• B084AC4121406070: 12D x 14W x 06H x 7L, PEEK-HA
• B084AC4121405070: 12D x 14W x 05H x 7L, PEEK-HA