CHANNEL CERVICAL CO81412-6

GUDID B528CO8141260

SPACER CERVICAL 8MM 6 DEG PEEK

PANTHEON SPINAL, LLC

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• Primary Device ID: B528CO8141260
• NIH Device Record Key: 28f1ae57-dc7b-4f7a-94aa-baed9b06ed94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHANNEL CERVICAL
• Version Model Number: 1
• Catalog Number: CO81412-6
• Company DUNS: 071012634
• Company Name: PANTHEON SPINAL, LLC
• 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: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM
• Phone: 5123083488
• Email: INFO@PANTHEON-SPINAL.COM

Device Dimensions

• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter
• Angle: 6 degree
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B528CO8141260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163494

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

[B528CO8141260]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-14
• Device Publish Date: 2021-01-06

On-Brand Devices [CHANNEL CERVICAL]

• B528CO8141260: SPACER CERVICAL 8MM 6 DEG PEEK
• B528C09141260: Spacer Cervical 9mm x 6 deg PEEK