Anterior Cervical IBFD AC1-111307-07

GUDID B084AC1111307070

KEOS

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: B084AC1111307070
• NIH Device Record Key: 01854fc8-aac3-4be9-8237-fc8ad8b68522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Cervical IBFD
• Version Model Number: 11D x 13W x 07H x 7L, PEEK
• Catalog Number: AC1-111307-07
• 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	B084AC1111307070 [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

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

[B084AC1111307070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-25
• Device Publish Date: 2023-12-15

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