Anterior Cervical IBFD AC1-141606-04

GUDID B084AC1141606040

KEOS

Polymeric spinal interbody fusion cage

• Primary Device ID: B084AC1141606040
• NIH Device Record Key: 53e91fa6-7027-4cab-b356-748ecf29d551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Cervical IBFD
• Version Model Number: 14D x 16W x 06H x 4L, PEEK
• Catalog Number: AC1-141606-04
• 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	B084AC1141606040 [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

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

[B084AC1141606040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-05
• Device Publish Date: 2024-01-26

On-Brand Devices [Anterior Cervical IBFD]

• B084AC1111312070: 11D x 13W x 12H x 7L, PEEK
• B084AC1111312040: 11D x 13W x 12H x 4L, PEEK
• B084AC1111312000: 11D x 13W x 12H x 0L, PEEK
• B084AC1111311070: 11D x 13W x 11H x 7L, PEEK
• B084AC1111311040: 11D x 13W x 11H x 4L, PEEK
• B084AC1111311000: 11D x 13W x 11H x 0L, PEEK
• B084AC1111310070: 11D x 13W x 10H x 7L, PEEK
• B084AC1111310040: 11D x 13W x 10H x 4L, PEEK
• B084AC1111310000: 11D x 13W x 10H x 0L, PEEK
• B084AC1111309070: 11D x 13W x 09H x 7L, PEEK
• B084AC1111309040: 11D x 13W x 09H x 4L, PEEK
• B084AC1111309000: 11D x 13W x 09H x 0L, PEEK
• B084AC1111308070: 11D x 13W x 08H x 7L, PEEK
• B084AC1111308040: 11D x 13W x 08H x 4L, PEEK
• B084AC1111308000: 11D x 13W x 08H x 0L, PEEK
• B084AC1111307070: 11D x 13W x 07H x 7L, PEEK
• B084AC1111307040: 11D x 13W x 07H x 4L, PEEK
• B084AC1111307000: 11D x 13W x 07H x 0L, PEEK
• B084AC1111306070: 11D x 13W x 06H x 7L, PEEK
• B084AC1111306040: 11D x 13W x 06H x 4L, PEEK
• B084AC1111306000: 11D x 13W x 06H x 0L, PEEK
• B084AC1111305070: 11D x 13W x 05H x 7L, PEEK
• B084AC1111305040: 11D x 13W x 05H x 4L, PEEK
• B084AC1111305000: 11D x 13W x 05H x 0L, PEEK
• B084AC2141612070: 14D x 16W x 12H x 7L, PEEK-HA
• B084AC2141611070: 14D x 16W x 11H x 7L, PEEK-HA
• B084AC2141610070: 14D x 16W x 10H x 7L, PEEK-HA
• B084AC2141609070: 14D x 16W x 09H x 7L, PEEK-HA
• B084AC2141608070: 14D x 16W x 08H x 7L, PEEK-HA
• B084AC2141607070: 14D x 16W x 07H x 7L, PEEK-HA
• B084AC2141606070: 14D x 16W x 06H x 7L, PEEK-HA
• B084AC2141605070: 14D x 16W x 05H x 7L, PEEK-HA
• B084AC2121412070: 12D x 14W x 12H x 7L, PEEK-HA
• B084AC2121411070: 12D x 14W x 11H x 7L, PEEK-HA
• B084AC2121410070: 12D x 14W x 10H x 7L, PEEK-HA
• B084AC2121409070: 12D x 14W x 09H x 7L, PEEK-HA
• B084AC2121408070: 12D x 14W x 08H x 7L, PEEK-HA
• B084AC2121407070: 12D x 14W x 07H x 7L, PEEK-HA
• B084AC2121406070: 12D x 14W x 06H x 7L, PEEK-HA
• B084AC2121405070: 12D x 14W x 05H x 7L, PEEK-HA
• B084AC1121412070: 12D x 14W x 12H x 7L, PEEK
• B084AC1121412040: 12D x 14W x 12H x 4L, PEEK
• B084AC1121412000: 12D x 14W x 12H x 0L, PEEK
• B084AC1121411070: 12D x 14W x 11H x 7L, PEEK
• B084AC1121411040: 12D x 14W x 11H x 4L, PEEK
• B084AC1121411000: 12D x 14W x 11H x 0L, PEEK
• B084AC1121410070: 12D x 14W x 10H x 7L, PEEK
• B084AC1121410040: 12D x 14W x 10H x 4L, PEEK
• B084AC1121410000: 12D x 14W x 10H x 0L, PEEK
• B084AC1121409070: 12D x 14W x 09H x 7L, PEEK